Senior GMP Technician

Job Title: Senior GMP Technician Job Description
The Senior GMP Technician leads and executes downstream manufacturing operations in a state-of-the-art, fast-growing gene therapy and biologics facility. This role focuses on advanced downstream processes, including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation, while ensuring strict adherence to cGMP standards, Standard Operating Procedures (SOPs), and batch records. The Senior GMP Technician acts as a technical expert on downstream equipment, drives process improvements, collaborates closely with Quality functions, and mentors junior team members in a highly regulated, cleanroom-based environment.
Responsibilities
- Lead and execute downstream manufacturing operations, including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, in accordance with SOPs, batch records, and cGMP requirements.
- Independently prepare, set up, operate, and shut down advanced downstream equipment such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems.
- Troubleshoot downstream processing and equipment issues, identify root causes, and implement corrective actions to ensure optimal performance and minimal downtime.
- Monitor critical process parameters during manufacturing operations, including flow rates, pressures, temperatures, and other key variables, and respond promptly to deviations or abnormalities.
- Analyze process data, identify trends or issues, and escalate or resolve deviations in a timely manner in alignment with regulatory and internal requirements.
- Perform in-process testing and quality control checks, such as pH, conductivity, and pressure measurements, to verify product quality and ensure adherence to specifications.
- Accurately document all manufacturing activities, process data, test results, and observations in batch records and related documentation in compliance with cGMP and company policies.
- Collaborate closely with Quality Assurance (QA) and Quality Control (QC) teams to investigate and resolve deviations, non-conformances, and quality incidents.
- Support and participate in deviation investigations, root cause analyses, and implementation of corrective and preventive actions to maintain compliance and improve processes.
- Drive continuous process improvements by evaluating new technologies, equipment, and methods, and leading implementation efforts to enhance efficiency, productivity, and compliance.
- Contribute to the introduction and optimization of digital and documentation systems, such as electronic quality or document management platforms, to support compliant operations.
- Mentor and train junior team members on downstream manufacturing processes, equipment operation, troubleshooting techniques, and adherence to cGMP guidelines.
- Provide day-to-day guidance to less experienced staff, reinforcing best practices in documentation, safety, and process execution.
- Ensure strict adherence to safety procedures and environmental health and safety guidelines while performing all manufacturing activities.
- Maintain a clean and controlled work area, including cleanroom environments, by following gowning procedures, cleaning protocols, and contamination control practices.
- Support audits and inspections by providing accurate documentation, explaining processes, and demonstrating compliance with regulatory and internal requirements.
- Stay current with advancements in gene therapy downstream manufacturing, regulatory expectations, and industry trends, and apply this knowledge to improve operations.
- Participate in cross-functional meetings and project teams to align manufacturing activities with production timelines and organizational goals.
- Flexibly support manufacturing schedules by working assigned shifts, including potential weekends and holidays, to meet production demands.
Essential Skills
- Bachelors degree in Biology, Biochemistry, Biomedical Engineering, or a related life science field, or equivalent experience.
- Prior experience working in a GxP or other regulated manufacturing environment.
- Hands-on downstream processing or biologics manufacturing experience in a cGMP setting.
- Extensive expertise with downstream processing techniques, including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation.
- Advanced experience operating downstream equipment such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems.
- Proficiency in conducting in-process testing and quality control checks, including pH, conductivity, and pressure measurements.
- Strong understanding of cGMP principles, SOPs, and regulatory guidelines as they apply to biologics and gene therapy manufacturing.
- Excellent attention to detail with the ability to accurately document experimental data, manufacturing activities, and process outcomes.
- Strong organizational skills with the ability to manage multiple tasks, prioritize effectively, and meet project timelines in a fast-paced environment.
- Demonstrated commitment to following SOPs, safety protocols, and regulatory requirements to ensure product quality and compliance.
- Proven leadership abilities, including experience mentoring and training junior team members in a manufacturing or laboratory environment.
- Ability and flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.
- Comfort working in cleanroom and controlled environments with strict contamination control procedures.
- Ability to use or learn electronic documentation and quality systems, such as digital platforms for batch records or quality management (e.g., systems similar to Veeva).
Additional Skills & Qualifications
- Experience working in a cleanroom environment for biologics or gene therapy manufacturing.
- Familiarity with downstream processing of biologics, including viral vectors and other complex modalities.
- Experience with electronic quality, documentation, or manufacturing execution systems.
- Strong analytical and problem-solving skills, with the ability to interpret process data and support root cause investigations.
- Effective communication skills, with the ability to collaborate with cross-functional teams such as QA, QC, and engineering.
- Proactive mindset with a focus on continuous improvement, process optimization, and adoption of new technologies.
- Ability to adapt to a dynamic, growing, and start-up-like environment while maintaining high standards of quality and compliance.
Work Environment
This role is based in a growing, state-of-the-art gene therapy and biologics manufacturing facility that operates in a start-up phase with significant opportunities for impact and growth. There are two openings: one on first shift (approximately 7:00 a.m. to 3:30 p.m., with flexibility required) and one on second shift (approximately 2:00 p.m. to 10:30 p.m., with flexibility required). Second shift hours include a shift differential for the time worked on that shift. Work takes place primarily in temperature-controlled laboratory, cleanroom, and office environments. The position requires regular standing, walking, and hand manipulation, as well as frequent use of laboratory and manufacturing equipment such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Team members must wear appropriate personal protective equipment (PPE) when working with chemicals, biological materials, or in controlled environments, and must follow cleanroom gowning procedures and contamination control practices. The environment emphasizes safety, regulatory compliance, collaboration with cross-functional teams, and adherence to cGMP standards while supporting a fast-paced and innovative manufacturing operation.
Job Type & Location
This is a Contract to Hire position based out of Grove City, OH.
Pay and Benefits
The pay range for this position is $37.00 - $38.00/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)
Workplace Type
This is a fully onsite position in Grove City,OH.
Application Deadline
This position is anticipated to close on Oct 2, 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.

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