Job Title: Principal Sterilization Microbiologist Location: Park Ridge, NJ area Hours / Schedule: M-F, 8am - 5pm, Full Time Type: Direct Hire Responsibilities As the Principal Sterilization Microbiologist, you will serve as the enterprise-wide technical expert and strategic lead in sterilization science, sterility assurance, and microbiological efficacy. This role is responsible for setting the technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization. This role will help enhance company position as an innovative and trusted partner in infection prevention and control. You will lead the strategic direction of sterilization efforts, including setting long-term goals, evaluating and recommending sterilization technologies, assessing risks and success likelihood, and conducting hands-on testing when necessary. Your expertise will directly impact product safety, regulatory success, and speed-to-market for critical medical devices and healthcare products. As a recognized authority, you will guide internal and external teams on the application of sterilization standards (e.g., ISO 11135, 11137, 11737, USP , etc.), and represent the company in regulatory interactions, technical forums, and industry partnerships. This role demands excellence in scientific judgment, cross-functional collaboration, and the ability to mentor others while setting long-term technical strategies aligned with corporate innovation and compliance goals. The Principal Scientist must demonstrate a high level of autonomy, demonstrating ownership, leadership, and coordination in driving projects to success while keeping leadership and the business updated on progress. A proactive approach in identifying opportunity areas, and a strong drive for results and organizational improvement are essential. Sterilization & Microbiological Expertise Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma irradiation, and vaporized hydrogen peroxide Define and execute strategies for bioburden reduction, biological indicator selection, and sterilization dose mapping and auditing Serve as subject matter expert on ISO 11135, 11137, 11737, USP , and related standards Provide technical leadership in method selection, packaging compatibility, and efficacy testing throughout the product lifecycle Assess and communicate technical risks and mitigation strategies to leadership and cross-functional teams Laboratory Leadership & Scientific Rigor Oversee microbiological method development, validation, and data interpretation for regulatory submissions Manage complex laboratory investigations and ensure scientific rigor across testing strategies Develop and maintain standard operating procedures (SOPs) and laboratory best practices Identify capability gaps and implement new technologies or infrastructure improvements Technical Project Ownership Own the end-to-end sterilization strategy and execution, ensuring alignment with product development timelines, regulatory requirements, and business goals Define project goals, align cross-functional teams, and secure resources to meet milestones Monitor progress, resolve challenges, and ensure delivery of high-quality outcomes Communicate updates and findings to senior leadership clearly and effectively Cross-Functional Collaboration Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements into project plans and quality systems Influence decision-making through technical insight and data-driven recommendations Provide technical leadership in the selection of sterilization methods, packaging compatibility assessments, and efficacy test strategies during new product introduction and product lifecycle management Innovation & Capability Building Drive implementation of new methods, technologies, and process improvements in microbiology and sterility assurance for both R&D and production environments Evaluate and adopt emerging technologies that strengthen internal capabilities Contribute to intellectual property development through patents and trade secrets. Mentorship & Knowledge Development Mentor and coach junior scientists, fostering technical growth and critical thinking Promote a culture of continuous improvement, collaboration, and scientific excellence Lead internal training on sterilization principles, regulatory standards, and laboratory practices Requirements Degree in Biological Science, or related discipline, required Masters / Ph.D. an advantage Expert Microbiology and Sterilization understanding Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC Strong knowledge of QbD principles and designing appropriate DOE studies to inform on risks 8-10 years' experience in microbiology for regulated products, 5+ years of direct sterilization experience Deep drug product development expertise with exposure to all stages and aspects of development (preclinical, clinical, and commercial) and cGMP industrial background Excellent communication skills (verbal / written); Ability to explain science to management Identifies opportunities and takes risks to achieve objectives Simplify complex ideas, collaborate effectively, deliver results, and innovate in sterility assurance Able to work on multiple projects of varying complexity Ability to evolve, learn and implement new systems and programs Initiative taker, ambitious and driven Resourceful and able to find creative and innovative ways to achieve results Computer literate (Outlook / Word / Excel, M365) Benefits As this is a direct hire position with our client, System One benefits described below would not apply to this role. Benefits program with the client would be those applicable to this role. Ref:<img src="https://www.jobg8.com/Tracking.aspx?4ZUswcWR7GsZCBwAXDtPWQz" width="0" height="0" />

**Principal Sterilization Microbiologist**

Join our team as a Principal Sterilization Microbiologist in the Park Ridge, NJ area. This full-time position offers an opportunity to serve as the enterprise-wide technical expert and strategic lead in sterilization science, sterility assurance, and microbiological efficacy.

**Job Description**

- Serve as the enterprise-wide technical expert and strategic lead in sterilization science, sterility assurance, and microbiological efficacy.
- Set the technical direction, lead high-impact sterilization programs, and ensure full regulatory compliance across the product lifecycle—from development through commercialization.
- Enhance the company's position as an innovative and trusted partner in infection prevention and control.
- Lead the strategic direction of sterilization efforts, including setting long-term goals, evaluating and recommending sterilization technologies, assessing risks and success likelihood, and conducting hands-on testing when necessary.
- Guide internal and external teams on the application of sterilization standards (e.g., ISO 11135, 11137, 11737, USP, etc.) and represent the company in regulatory interactions, technical forums, and industry partnerships.
- Demonstrate excellence in scientific judgment, cross-functional collaboration, and the ability to mentor others while setting long-term technical strategies aligned with corporate innovation and compliance goals.
- Demonstrate a high level of autonomy, ownership, leadership, and coordination in driving projects to success while keeping leadership and the business updated on progress.
- Identify opportunity areas proactively and drive results and organizational improvement.

**Requirements**

- Degree in Biological Science or related discipline required; Masters/Ph.D. is an advantage.
- Expert understanding of microbiology and sterilization.
- Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.
- Strong knowledge of QbD principles and designing appropriate DOE studies to inform on risks.
- 8-10 years' experience in microbiology for regulated products; 5+ years of direct sterilization experience.
- Deep drug product development expertise with exposure to all stages and aspects of development (preclinical, clinical, and commercial) and cGMP industrial background.
- Excellent communication skills (verbal/written); ability to explain science to management.
- Ability to identify opportunities and take risks to achieve objectives.
- Ability to simplify complex ideas, collaborate effectively, deliver results, and innovate in sterility assurance.
- Ability to work on multiple projects of varying complexity.
- Initiative taker, ambitious, driven, resourceful, and able to find creative and innovative ways to achieve results.
- Computer literate (Outlook/Word/Excel, M365).

**Benefits**

As this is a direct hire position with our client, System One benefits described below would not apply to this role. Benefits program with the client would be those applicable to this role.

Principal Sterilization Microbiologist

Job Title: Clinical Data Manager Location: Remote Type: Contract Compensation: $70 - $75 hourly W2 only As a Clinical Data Temp, a typical day may include: Serves as primary Data Manager contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with clients SOPs and policies and practices including, not limited to: Monitors data clean-up process performed by CROs from study start-up through data archiving. Provides data for analysis. Coordinates activities including: medical coding; data validation checks and database snapshot. Prepares and distributes project status reports to project team and management. Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with client SOPs. Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF. Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Contributes to upkeep DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization. Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures. To be considered for this role, you must meet the following requirements Bachelor's degree in Mathematics, Science or a related field, along with 3 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry. Experience 3 - 5 Years Previous oncology and/or ophthalmology experience a plus System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref:<img src="https://www.jobg8.com/Tracking.aspx?MQqRzalZexyHfu6JlFsyRwh" width="0" height="0" />

**Clinical Data Manager**

As a Clinical Data Temp, a typical day may include serving as the primary Data Manager contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned studies. 

**Job Description**

- Coordinates, leads, and performs clinical data management activities for assigned studies in accordance with clients' SOPs and policies and practices, including monitoring the data clean-up process performed by CROs from study start-up through data archiving.
- Provides data for analysis and coordinates activities including medical coding, data validation checks, and database snapshots.
- Prepares and distributes project status reports to the project team and management.
- Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with client SOPs.
- Creates and maintains project documentation, including but not limited to Data Management Manual, CRF Completion Guidelines, validation specifications, and work instructions for assigned projects.
- Designs and modifies CRF.
- Responsible for the initiation and approval of the building, testing, and validation of clinical databases, subsequent changes in clinical databases, and data validation activities.
- Contributes to the upkeep of DM outsourcing strategies and long-term relationships with outsourcing partners with the objective of ensuring data quality and efficiencies through data and process standardization.
- Works with the study team and coordinates all data management functions.
- Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures.

**Requirements**

- Bachelor's degree in Mathematics, Science, or a related field.
- 3 or more years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
- Previous oncology and/or ophthalmology experience is a plus.

**Benefits**

- System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. 

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Clinical Data Manager - Oncology

Job Title: Surgical Planning Technician Location: Portage, MI Hours/Schedule: M-F, 3:30pm-12:00am Type: Contract Responsibilities Create cases to be completed using a proprietary case management system. Review CT Scans for conformity to Mako Surgical protocol. Segment CT Scans using specialized software to create 3D Anatomical Bone Models for use in Robotic Surgery. Create Pre-Operative Surgical Plans using the previously created Digital Bone Models for robotically assisted Total Hip and Total Knee Replacement. Review CT segmentations and Surgical Plans for accuracy of anatomical landmark selection and implant sizing and positioning. Upload completed Pre-plans to field based personnel. Document all activities according to prescribed methods and procedures. Follow work instructions exactly to deliver consistent output Requirements High School Diploma or equivalent. Minimum of 2 Years' work experience required, or equivalent education (Associate's Degree or above) Computer skills: Proficiency in Microsoft Office Suite, experience in Salesforce or Materialize MIMICS, knowledge of Adobe Photoshop are all considered a plus Certifications or related experience in Radiology (CT, X-Ray, MRI) Certification in Nursing or related field College level anatomy course completion Demonstrated customer service orientation Demonstrated interpersonal and communication skills Demonstrated efficient work methods and an ability to handle multiple tasks in a fast-paced environment. Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref:<img src="https://www.jobg8.com/Tracking.aspx?7MluQ%2bD0cDQEa9DHQ8jlSwe" width="0" height="0" />

**Surgical Planning Technician**

Join our team as a Surgical Planning Technician in Portage, MI. This position offers a unique opportunity to work with advanced technology in a dynamic environment.

**Job Description**

- Create cases to be completed using a proprietary case management system.
- Review CT scans for conformity to Mako Surgical protocol.
- Segment CT scans using specialized software to create 3D anatomical bone models for use in robotic surgery.
- Create pre-operative surgical plans using the previously created digital bone models for robotically assisted total hip and total knee replacement.
- Review CT segmentations and surgical plans for accuracy of anatomical landmark selection and implant sizing and positioning.
- Upload completed pre-plans to field-based personnel.
- Document all activities according to prescribed methods and procedures.
- Follow work instructions exactly to deliver consistent output.

**Requirements**

- High school diploma or equivalent.
- Minimum of 2 years' work experience required, or equivalent education (Associate's degree or above).
- Proficiency in Microsoft Office Suite; experience in Salesforce or Materialize MIMICS, knowledge of Adobe Photoshop are all considered a plus.
- Certifications or related experience in radiology (CT, X-Ray, MRI).
- Certification in nursing or related field.
- College-level anatomy course completion.
- Demonstrated customer service orientation.
- Demonstrated interpersonal and communication skills.
- Demonstrated efficient work methods and an ability to handle multiple tasks in a fast-paced environment.

**Benefits**

- System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Surgical Planning Technician

Job Title: Specimen Processor Location: New Haven, CT Type: Contract Overview Leading pharmaceutical company looking for an experienced Specimen Processor. Ideal candidates should have a strong background in sample and specimen processing, quality control/compliance experience, and inventory maintenance experience. Responsibilities Ensuring that samples acquired during the conduct of a drug trial are processed, stored, shipped in a manner that maintains specimen integrity. Review of queried reports to QC sample processing and bring to the attention of Operations Director any major protocol deviations and or discrepancies. Support sample processing and verification of specimen compliance Identify day to day requirements for study sample processing and ensure that Laboratory is prepared to support these tasks. Maintain proper inventory of items necessary to support the processing and storage of clinical trial samples Oversee the requisitioning and transport of safety samples that are outsourced. Own it. Perform the duties and requirements of Laboratory Study Co-lead. Record daily schedule for the following day by printing Dashboard schedule, 2 copies, deliver to SPL and Safety Lab. Display brief summary of next day's activities (including date) on the white board by the dumbwaiter. Ensuring that samples acquired during the conduct of a drug trial are processed, stored, shipped in a manner that maintains specimen integrity. Once or twice a day, review of queried reports (Toad) to QC sample processing and bring to the attention of the Laboratory Manager or Specimen Processing Lead any major protocol deviations and or discrepancies who will then review issues with the lab. Document discrepancies on the electronic copy and save to the TAT folder. Also include investigation comments in an additional column Review daily Specimen Processing bench logs for compliance Identify day to day requirements for study sample processing and ensure that Laboratory is prepared to support these tasks with trained personnel Maintain inventory of items necessary to support the processing and storage of clinical trial samples Enter send out results as performed. Exhibit behavior by example, staying busy, ensuring the lab is covered at all times and new staff is not left alone Requirements Strong background Sample and Specimen Processing (logging and reviewing for accuracy) QC Exp./Compliance Exp. Inventory Maintenance Cerner Lab Experience High School Diploma Associates preferred Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref:<img src="https://www.jobg8.com/Tracking.aspx?jGWdOhq9UXvVoRA3PsFN0Qn" width="0" height="0" />

**Specimen Processor**

Leading pharmaceutical company looking for an experienced Specimen Processor. Ideal candidates should have a strong background in sample and specimen processing, quality control/compliance experience, and inventory maintenance experience.

**Job Description**

- Ensuring that samples acquired during the conduct of a drug trial are processed, stored, and shipped in a manner that maintains specimen integrity.
- Review of queried reports to QC sample processing and bring to the attention of Operations Director any major protocol deviations and or discrepancies.
- Support sample processing and verification of specimen compliance.
- Identify day-to-day requirements for study sample processing and ensure that the laboratory is prepared to support these tasks.
- Maintain proper inventory of items necessary to support the processing and storage of clinical trial samples.
- Oversee the requisitioning and transport of safety samples that are outsourced.
- Perform the duties and requirements of Laboratory Study Co-lead.
- Record daily schedule for the following day by printing Dashboard schedule, 2 copies, deliver to SPL and Safety Lab.
- Display brief summary of next day's activities (including date) on the whiteboard by the dumbwaiter.
- Once or twice a day, review of queried reports (Toad) to QC sample processing and bring to the attention of the Laboratory Manager or Specimen Processing Lead any major protocol deviations and or discrepancies who will then review issues with the lab.
- Document discrepancies on the electronic copy and save to the TAT folder. Also include investigation comments in an additional column.
- Review daily Specimen Processing bench logs for compliance.
- Identify day-to-day requirements for study sample processing and ensure that the laboratory is prepared to support these tasks with trained personnel.
- Maintain inventory of items necessary to support the processing and storage of clinical trial samples.
- Enter send out results as performed.
- Exhibit behavior by example, staying busy, ensuring the lab is covered at all times and new staff is not left alone.

**Requirements**

- Strong background in sample and specimen processing (logging and reviewing for accuracy).
- Quality control experience/compliance experience.
- Inventory maintenance experience.
- Cerner Lab experience.
- High School Diploma; Associates preferred.

**Benefits**

- System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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