Sr. Cleaning Validation Engineer / SME (Onsite / So. California)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

This is 100% onsite in So. California. Must be comfortable in a Lead role.

Job Responsibilities

• Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning, designing and development of projects.
• Write and review technical documentation (cleaning cycle development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing, cleaning validation master plans)
• Creation, execution of Cleaning Validation Protocols, including identification and resolution of non-conformances/deviations.
• Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections.
• Manage contractors performing system qualifications, ensure the quality of completed deliverables.
• Report status and progress of qualification activities or projects to the Leadership team.

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Knowledge & Skills

• Demonstrated knowledge of cleaning validation principles, methodology and life-cycle  associated practices.
• Proven experience and expertise in executing cleaning studies for biological products.
• Experience with cleaning validation programs in multi-product facilities, including biological products, complex small molecule formulations, potent and non-potent products.
• Demonstrated ability to use a risk-based approach for defining cleaning validation approach for new products.
• Demonstrated knowledge of biopharmaceutical manufacturing including drug product formulation and fill/finish operations.
• Experience with automated cleaning processes (CIP and parts washers) as well as manual cleaning and sanitization operations.
• Experience with qualification of automated cleaning processes and oversight of cleaning cycle development activities.

Education & Experience

• A Bachelor’s Degree in Science, Engineering or a related field with a minimum of seven (7) years of experience.
• Knowledge of the cleaning validation role inside of a cGMP manufacturing environment.
• Experience working with the regulations and requirements for biologics or pharmaceuticals.
• Knowledge of scientific and engineering principles in the biopharmaceutical industry.
• Proven track record to create, review, and execute qualification protocols and associated validation lifecycle documentation, including identification and resolution of non-conformances /deviations.
• Automated equipment and system qualification experience in a cGMP environment for process and manufacturing equipment and systems.
• Knowledge and experience with life-cycle approach to cleaning validation in multi-product facility.

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***