Cleaning Validation Engineer Lead

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

The Cleaning Validation Engineer Lead is responsible for leading the cleaning validation workstream supporting biopharmaceutical manufacturing operations. This role will provide technical and execution leadership for cleaning validation activities associated with production equipment, including harvest centrifuges, production bioreactors, CIP systems, and related process equipment.

The individual will oversee the development, modification, execution, review, and reporting of cleaning validation activities while ensuring alignment with GMP requirements, approved validation strategies, and client quality standards. As a workstream lead, this position will coordinate validation resources and execution activities, monitor deliverables and project priorities, provide technical guidance, and collaborate cross-functionally to drive the successful completion of cleaning validation milestones.

• Lead the cleaning validation workstream, including planning, coordination, execution, documentation, and completion of validation deliverables.

• Provide technical leadership and direction to engineers and other team members supporting cleaning validation activities.

• Develop, modify, review, approve, execute, and manage cleaning validation protocols for harvest centrifuges, production bioreactors, CIP systems, and associated manufacturing equipment.

• Establish workstream priorities, coordinate resources, and track cleaning validation activities against project schedules and milestones.

• Oversee protocol execution and ensure activities are completed in accordance with approved procedures, validation strategies, and acceptance criteria.

• Generate and review cleaning validation reports, ensuring execution results, deviations, conclusions, and supporting documentation are complete and technically sound.

• Lead the authoring, execution, review, and routing of validation protocols and associated documentation within Kneat.

• Coordinate and oversee on-site protocol execution activities, including swab and rinse sampling.

• Ensure sampling activities are appropriately planned, coordinated, documented, and executed in accordance with approved protocols and site procedures.

• Lead or support the investigation and resolution of protocol discrepancies, deviations, unexpected results, and documentation issues.

• Identify risks, constraints, and potential schedule impacts within the cleaning validation workstream and coordinate appropriate resolution with project stakeholders.

• Maintain oversight of cleaning validation documentation to ensure completeness, accuracy, traceability, and compliance with GMP requirements and client procedures.

• Serve as a key cleaning validation point of contact for Quality, Manufacturing, Engineering, Validation, and other project stakeholders.

• Provide technical guidance regarding cleaning validation strategies, execution approaches, acceptance criteria, and validation lifecycle requirements.

• Support workstream planning, progress reporting, issue escalation, and communication of cleaning validation status to project leadership.

• Ensure cleaning validation activities remain aligned with project timelines, quality requirements, and established site procedures.

• Complete all required site training and ensure adherence to site-specific safety, quality, and operational standards.

Requirements

• Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related technical discipline.

• 10+ years of experience in Cleaning Validation, CQV, Validation, or Quality Engineering within the pharmaceutical, biotechnology, or life sciences industry.

• Demonstrated experience leading cleaning validation workstreams, projects, or teams within GMP-regulated manufacturing environments.

• Extensive hands-on experience developing, modifying, reviewing, executing, and managing cleaning validation protocols.

• Strong experience with cleaning validation of centrifuges, bioreactors, CIP systems, and process equipment.

• Experience overseeing and performing swab and rinse sampling activities within GMP manufacturing environments.

• Experience generating, reviewing, and approving validation reports and supporting documentation.

• Demonstrated ability to coordinate validation resources, execution schedules, deliverables, and cross-functional activities.

• Strong understanding of GMP requirements, cleaning validation principles, validation lifecycle methodologies, risk-based validation approaches, and good documentation practices.

• Kneat experience is required, including protocol authoring, execution, review, and routing.

• Experience supporting the investigation and resolution of deviations, discrepancies, and validation execution issues.

• Ability to provide technical direction and effectively communicate risks, priorities, and project status to cross-functional stakeholders and project leadership.

• Strong technical writing, leadership, communication, organizational, and problem-solving skills.

• Ability to work on-site and provide leadership during hands-on execution activities in manufacturing environments.

• Must be authorized to work in the U.S.

• No C2C at this time

Benefits

• Equal Opportunity Employment Statement

• PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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