Quality Engineer III - Process Validation

Job Title: Quality Engineer III – Process ValidationJob Description The Quality Engineer III – Process Validation plays a critical role in ensuring product quality and compliance across the entire lifecycle, from New Product Introduction (NPI) through Process Performance Qualification (PPQ) and into commercial manufacturing. This high-level individual contributor position provides phase-appropriate quality assurance oversight, supports technology transfer and process validation, and ensures programs are inspection-ready and aligned with commercialization quality strategies. The role is highly cross-functional and directly supports successful product launches and sustained commercial operations in a fast-paced biologic drug substance manufacturing environment. Responsibilities Serve as the Quality representative and lead on cross-functional program teams to enable successful commercialization readiness from late-stage development through launch and post-launch support.Provide phase-appropriate QA oversight for technology transfer, process validation and PPQ readiness, control strategy implementation, and manufacturing scale-up activities.Partner with product and program leadership to ensure quality deliverables, timelines, and risk mitigations are 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 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 in accordance with GMP and quality standards.Conduct compliance walkthroughs on the manufacturing floor to ensure adherence to GMP requirements and quality procedures.Provide QA support during manufacturing hypercare and critical operations, offering on-floor oversight over processes when needed.Support and lead investigations for deviations, corrective and preventive actions (CAPAs), and change controls, including root cause analysis and documentation of outcomes.Apply risk-based decision-making principles to drive compliant, effective, and pragmatic quality outcomes.Identify, assess, and mitigate quality risks across operations, proactively addressing potential issues before they impact product or patient safety.Contribute to continuous improvement initiatives focused on enhancing quality systems, inspection readiness, and operational efficiency.Utilize tools such as Smartsheet and other documentation systems to manage and track quality activities, batch record reviews, and project deliverables.Communicate clearly with internal and external stakeholders to document, explain, and justify quality decisions and risk assessments.Influence cross-functional teams, manage competing priorities, and make sound quality decisions under timeline pressure.Collaborate with manufacturing, technical, and other departments to identify and implement solutions to address quality and compliance issues.Provide independent quality oversight with minimal guidance, demonstrating leadership in decision-making and change implementation.Support inspection readiness activities and respond to regulatory technical reviews related to FDA and GMP expectations.When required, aseptically gown and work in environmental clean rooms to provide on-site quality oversight of validation and manufacturing processes. Essential Skills Bachelor’s degree in a scientific discipline or equivalent experience.Typically 5+ years of experience in a regulated GMP manufacturing environment such as biopharma, pharma, medical devices, or similar, including direct Quality oversight.Experience supporting New Product Introduction (NPI), Process Performance Qualification (PPQ or PPI), and/or commercial manufacturing activities.Strong knowledge of quality systems and their application in a regulated manufacturing environment.Demonstrated process validation experience, including regulatory technical review aligned with FDA and GMP requirements.Strong working knowledge of current Good Manufacturing Practices (cGMP), data integrity expectations, and inspection readiness principles.Hands-on GMP pharmaceutical quality assurance experience, including on-floor QA oversight over manufacturing processes.Experience with CAPAs, including investigation, root cause analysis, and implementation of corrective and preventive actions.Proficiency in reviewing and working with SOPs and batch records, including batch record review for release.Ability to apply risk-based decision-making to complex quality and operational scenarios.Effective written and verbal communication skills, with the ability to document and explain quality decisions to internal and external stakeholders.Strong attention to detail and accuracy in documentation and review.Ability to perform job functions with minimal guidance and manage multiple priorities in a fast-paced environment.Proven ability to make key and timely decisions and provide independent quality judgment.Ability to influence cross-functional teams and lead significant change related to quality and compliance.Excellent organizational skills and problem-solving abilities. Additional Skills & Qualifications Technical knowledge of biopharmaceutical manufacturing processes is highly desirable.Experience with Smartsheet or similar tools for tracking quality activities and documentation is beneficial.Experience in inspection readiness and participation in regulatory inspections or audits is an advantage.Leadership experience, including influencing others and leading cross-functional initiatives, is a plus.Ability to work collaboratively with various departments and external partners to identify and implement solutions to quality and compliance issues.Ability to aseptically gown and work in environmental clean rooms as needed to support on-floor quality oversight.Strong capability to manage competing priorities while maintaining high quality standards and meeting timelines.Demonstrated commitment to continuous improvement in quality systems and manufacturing processes. Work Environment This role is based at a fast-paced biologic drug substance manufacturing facility focused on cell process development to support clinical and commercial manufacturing of products that treat chronic health conditions, including cancers and other life-threatening diseases. The site operates around the clock and employs approximately 1,000 people, offering exposure to advanced biologics manufacturing technologies and a highly collaborative environment. The typical work schedule is Monday through Friday, with a flexible start time and standard hours around 8:00 a.m. to 5:00 p.m. The position is primarily desk-based for documentation, review, and cross-functional collaboration, but requires regular presence on the manufacturing floor for process validation and QA oversight. When entering clean rooms or controlled areas, you will need to gown appropriately and be comfortable wearing full cleanroom attire such as bunny suits (whites) or blues (scrub-like garments). The culture emphasizes scientific excellence, quality, and a mission-driven focus on enabling customers to make the world healthier, cleaner, and safer, with a strong commitment to supporting scientific research, discovery, and patient impact. 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 9, 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 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 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.