Manufacturing Support Associate

About the role

Contract to Hire position based out of Allendale, NJ. Fully onsite.

Responsibilities

• 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 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 CAPA’s
• Own technology transfer activities such as creation of MBRs, eBRs, and protocol/report generation for APS.

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

Qualifications

• 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