Production Support Associate

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

Responsibilities

• Produce high-level 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 eBR platform.
• Support Performance Qualification (PQ) execution activities.
• Assist in authoring and executing PQ protocols/reports for eBR implementations.
• Troubleshoot routine eBR issues and escalate as needed.
• Own and drive change controls and CAPAs related to MBR, eBR, 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 CAPAs.
• Own technology transfer activities such as creation of MBRs, eBRs, and protocol/report generation for APS.

Requirements

• 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 eBR 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 suggest improvements and adaptations to methodologies, processes, and products.

Skills

• Strong technical writing and documentation skills.
• Understanding of manufacturing processes and batch record/eBR 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.

Pay

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

Benefits

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, and vision
• Critical Illness, Accident, and Hospital insurance
• 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)

Schedule

This is a fully onsite position in Allendale, NJ.