Key Responsibilities:

1. Cleaning Validation Protocol Development:

- Develop, write, and review cleaning validation protocols, reports, and standard operating procedures (SOPs) in accordance with GMP regulations and global procedures.

- Establish acceptance criteria for cleaning validation based on product residues, cleaning agents, and microbial contaminants.

2. Validation Execution:

- Plan and execute cleaning validation studies, including surface sampling, rinse sampling, and swabbing of equipment and facilities.

- Conduct analytical testing associated to cleaning validation, to include Total Organic Carbon (TOC) testing

- Coordinate with production and quality control to schedule and perform validation activities.

3. Data Analysis and Reporting:

- Analyze cleaning validation data to ensure compliance with established acceptance criteria.

- Prepare detailed validation reports summarizing findings, deviations, and corrective actions.

4. Regulatory Compliance:

- Ensure all cleaning validation activities comply with relevant GMP guidelines, including FDA, EMA, and other regulatory bodies.

-Align local site based procedures with global SOP’s.

- Stay current with regulatory updates and industry best practices related to cleaning validation.

5. Continuous Improvement:

- Identify opportunities for process improvements in cleaning procedures and validation practices.

- Participate in root cause analysis and implement corrective and preventive actions (CAPAs) for cleaning validation deviations.

6. Training and Documentation:

- Provide training to production and quality staff on cleaning procedures and validation requirements.

- Maintain comprehensive and up-to-date documentation of all cleaning validation activities.

7. Cross-Functional Collaboration:

- Work collaboratively with production, quality assurance, quality control, and regulatory affairs to ensure cleaning validation requirements are met.

- Site representative for the global cleaning validation team to align on bets practices, globally

- Support internal and external audits related to cleaning validation processes.

Qualifications:

- Education: Bachelor’s degree in Chemistry, Microbiology, Engineering, or a related field. Advanced degree preferred.

- Experience: Minimum of 3-5 years of experience in cleaning validation within a GMP-regulated pharmaceutical manufacturing environment.

- Knowledge: Strong understanding of GMP regulations, cleaning validation principles, and pharmaceutical manufacturing processes.

- Skills:

- Proficiency in writing technical documents and validation protocols.

- Excellent analytical and problem-solving skills.

- Strong attention to detail and organizational skills.

- Effective communication and interpersonal skills.

- Ability to work independently and as part of a team.

Physical Requirements:

- Ability to work in manufacturing and laboratory environments.

- Capability to lift and move equipment or materials as needed.

Work Environment:

- The role requires working in a controlled, GMP-regulated manufacturing environment.

- Occasional off-hours work may be required to meet project deadlines or address urgent validation needs.

Salary: $90k-$100k

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.