Production Support Specialist

Job Title: Production Support Associate



Essential Functions and 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.

Knowledge, Skills & Ability

• 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

Education & Experience

• 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 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.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 31, 2026.

About Actalent

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 many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.