Cleaning Validation Engineer III - PCI Pharma Services : Job Details

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Join to apply for the Cleaning Validation Engineer III role at PCI Pharma Services

Why work for PCI Pharma Services?At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

Why work for PCI Pharma Services?At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Job DetailsWe are currently seeking a Cleaning Validation Engineer III who plays a critical role in ensuring that cleaning validation activities within commercial and clinical fill and finish facilities are compliant with both internal and regulatory standards. This position is responsible for minimizing product cross-contamination risks through the development, validation, and continuous improvement of cleaning processes and procedures. Acting as the Subject Matter Expert (SME) for cleaning verification and validation, the Cleaning Validation Engineer III works across the site to manage all aspects of cleaning procedures for direct, indirect, and non-product contact surfaces in the manufacturing environment.Responsibilities

• Leads and executes cleaning validation studies, ensuring all activities are in compliance with FDA, EMA, and other relevant regulatory standards. Develops, authors, and implements cleaning validation protocols for pharmaceutical manufacturing environments and associated equipment.
• Performs comprehensive risk assessments related to cross-contamination and GMP risks. Regularly evaluates and updates cleaning processes to ensure they are appropriate for the level of potential contamination, minimizing the risk of product cross-contamination in a multi-product facility.
• Prepares, executes, and reports on cleaning validation testing across various phases of commissioning and qualification. Maintains thorough documentation in accordance with internal standards and regulatory expectations.
• Assesses the adequacy of existing cleaning methods, ensuring they are suitable for intended use, especially with respect to contamination levels. Develops product-specific cleaning procedures using appropriate cleaning agents and performs GAP assessments to evaluate the effectiveness of cross-contamination controls.
• Analyzes cleaning validation data, including rinse and swab results, and identifies corrective actions where necessary. Troubleshoots and resolves any issues in cleaning validation processes to maintain compliance and operational efficiency.
• Works closely with teams across manufacturing, quality assurance, quality control, and engineering to define cleaning validation requirements and ensure adherence to project timelines. Leads efforts to optimize cleaning cycles, including CIP (Clean-in-Place) and COP (Clean-out-of-Place) systems.
• Ensures compliance with site EHS policies, cGMP regulations, and the company's Quality Management System (QMS). Tracks the validation lifecycle, ensuring documentation and practices are always audit-ready.
• Organizes, schedules, and tracks validation projects, ensuring timelines are met and deliverables are in accordance with client and regulatory requirements. Manages deviations, protocol discrepancies, and associated risk analyses.

Requirements

• Bachelors degree in Engineering, Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field, required
• Minimum of 5 years of experience in cleaning validation in the pharmaceutical and biotechnology industries.
• Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
• Experience in cleaning validation within the pharmaceutical or biotech industry.
• Knowledge of regulatory requirements such as FDA, cGMP, and industry guidelines related to cleaning validation.
• A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.
• Strong understanding of validation principles and practices for cleaning processes and equipment.
• Excellent communication and collaboration skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Proven experience with Cat 1-4 materials and ADE values preferred.

The base hourly range for this position is $105,635.08 - $138,646.04 USD plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.Join us and be part of building the bridge between life changing therapies and patients. Let's talk futureEqual Employment Opportunity (EEO) StatementPCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesPharmaceutical Manufacturing

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