MSAT

Job Description

Job Title: MSAT Support

• Produce high level of technical documents, such as Master Batch Records (MBRs), protocols, reports, SOPs, and work instructions.
• Develop, revise, and maintain MBRs/eBRs in compliance with GMP and regulatory requirements.
• Translate paper-based MBRs into compliant eBRs.
• Ensure alignment of MBRs/eBRs with process requirements, equipment capabilities, and quality standards.
• Create and revise Aseptic Process Simulation (APS) documentation (Protocols, MBRs, eBRs, Risk Assessments, and Reports)
• Support configuration workflows, parameters, calculations, and logic within the e  platform.
• Support Performance Qualification (PQ) execution activities.
• Assist in authoring and executing PQ protocols/reports for e  implementations.
• Troubleshoot routine e  issues and elevate as needed.
• Own and drive change controls and CAPAs related to M , e  and APS documentation.
• Collaborate cross functionally with Manufacturing, Quality Assurance, Quality Control, Manufacturing Science and Technology, Supply Chain Management, and Project Management.
• Meet client-driven timelines and deliverables while managing multiple priorities.
• Participate in continuous improvement initiatives to optimize batch record accuracy, efficiency, and compliance.
• Perform impact assessments for changes to MBRs/eBRs and implement updates through change control processes.
• Execute assignments in alignment with pre-planned scope of work, timeline, and budget.
• Execute, manage and provide support for investigations, deviations, and CAPA’s
• Own technology transfer activities such as creation of MBRs, eBRs, and protocol/report generation for APS.

• Strong technical writing and documentation skills.
• Understanding of manufacturing processes and batch record/e  design principles.
• Knowledge of risk management methodologies (e.g., FMEA).
• Proficiency with document management systems and change control processes.
• Strong attention to detail and data integrity mindset.
• Excellent problem-solving and analytical skills.
• Effective cross-functional communication skills.
• Ability to manage multiple projects and deadlines in a fast-paced manufacturing environment.
• Continuous improvement mindset

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical field
• Minimum of 2 years combined industry/academic experience in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for manufacture of cell therapy products.
• Basic understanding of e  platforms and validation principles
• Experience with Electronic Batch Record Systems
• Demonstrated excellence in technical writing in the preparation of protocols and reports, presentations and/or other communications
• Ability to provide technical solutions to a variety of technical problems of low complexity scope and the ability to suggest improvements and adaptations to methodologies, processes, products

This is a Contract to Hire position based out of Allendale, NJ.

The pay range for this position is $34.00 - $34.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Allendale,NJ.

This position is anticipated to close on Aug 18, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves m