Sr. Process Validation Engineer **36-48/HR**

Sr. Process Validation Engineer

Job Description Sr. Process Validation Engineer responsible for providing quality assurance leadership across the full product lifecycle, from New Product Introduction (NPI) and Process Performance Qualification (PPQ) through commercial manufacturing. This role ensures programs are compliant, inspection-ready, and aligned with commercialization quality strategies, while partnering closely with cross-functional teams to support successful product launches and sustained commercial operations in a regulated GMP environment. Responsibilities

- Serve as the Quality representative and lead on cross-functional program teams to support commercialization readiness from late-stage development through product launch and post-launch support.
- Provide phase-appropriate QA oversight for technology transfer activities, including process validation and PPQ readiness, control strategy implementation, and manufacturing scale-up.
- Partner with product and program leadership to ensure quality deliverables, timelines, and risk mitigations are fully integrated into program plans, including risk assessments, readiness reviews, and documentation strategies.
- Ensure alignment with applicable regulations and guidance, such as FDA, EMA, and ICH, as well as internal site quality standards.
- Review and approve GMP documentation, including batch records, standard operating procedures (SOPs), technical reports, and quality records such as work notifications.
- Support material disposition and product release activities by applying appropriate quality oversight and decision-making.
- Conduct compliance walkthroughs on the manufacturing floor to verify adherence to GMP standards and identify areas for improvement.
- Provide QA support during manufacturing hypercare periods and critical operations, ensuring issues are promptly identified and addressed.
- Support and lead investigations for deviations, corrective and preventive actions (CAPAs), and change controls, including root cause analysis and documentation.
- Apply risk-based decision-making to ensure outcomes are both compliant and effective, balancing quality requirements with operational realities.
- Identify, assess, and mitigate quality risks across operations, proactively addressing potential issues before they impact product quality or compliance.
- Contribute to continuous improvement initiatives by recommending and implementing enhancements to quality systems, processes, and documentation.
- Provide on-floor QA oversight over manufacturing processes, including review and approval of batch records and support for process validation and PPQ activities.
- Utilize tools such as Smartsheet and audit practices to track, manage, and report on quality-related activities and documentation.
- Communicate clearly with internal and external stakeholders, documenting and explaining quality decisions and rationales.
- Manage multiple priorities with minimal guidance, making timely and sound quality decisions under timeline pressure.
- Influence cross-functional teams and lead significant change initiatives to address quality and compliance issues, working collaboratively with various departments to implement solutions.

Essential Skills

- Typically 5+ years of experience in a regulated GMP manufacturing environment (biopharma, pharma, medical devices, or similar), including direct Quality oversight.
- Demonstrated experience supporting New Product Introduction (NPI), Process Performance Qualification (PPQ or PPI), and/or commercial manufacturing.
- Strong knowledge of quality systems and their application in a regulated environment.
- Hands-on process validation experience, including regulatory technical review related to FDA and GMP requirements.
- Strong working knowledge of current Good Manufacturing Practices (cGMP), data integrity expectations, and inspection readiness principles.
- Experience with GMP documentation such as batch records and standard operating procedures (SOPs).
- Experience with CAPAs, deviations, change controls, and root cause analysis in a GMP setting.
- Ability to provide on-floor QA oversight over manufacturing processes.
- Risk-based decision-making skills, with the ability to balance compliance and operational needs.
- Effective written and verbal communication skills, including the ability to document and explain quality decisions to internal and external stakeholders.
- Strong attention to detail and organizational skills.
- Proven ability to perform job functions with minimal guidance and manage multiple priorities.
- Demonstrated decision-making and leadership skills, including the ability to make key and timely decisions.
- Ability to influence cross-functional teams and lead significant change to address quality and compliance issues.

Additional Skills & Qualifications

- Technical knowledge of biopharmaceutical manufacturing is desirable.
- Experience with biologic drug substance manufacturing and cell process development is a plus.
- Experience using tools such as Smartsheet for tracking and managing quality activities.
- Audit experience related to GMP and quality systems.
- Proven ability to work collaboratively with various departments and external partners to identify and implement solutions for quality and compliance issues.
- Strong problem-solving abilities and a continuous improvement mindset.
- Ability to aseptically gown and work in environmental clean rooms as needed.
- Leadership experience or demonstrated independent decision-making in a quality role is a plus.

Work Environment This role is based at a fast-paced biologic drug substance manufacturing facility focused on cell process development to support both clinical and commercial manufacturing.
Job Type & Location
This is a Contract to Hire position based out of Saint Louis, MO.
Pay and Benefits
The pay range for this position is $36.00 - $48.00/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 Saint Louis,MO.
Application Deadline
This position is anticipated to close on Sep 24, 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 without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
adjustment of the job application process or interviewing process due to a disability,
please email [email protected] for other accommodation options.

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

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall 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 applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.