Job Summary
We are seeking a Cleaning Validation Specialist to support cleaning validation activities within a pharmaceutical manufacturing environment. The role will involve preparing validation documentation, performing equipment swabbing and rinse sampling, reviewing validation data, supporting investigations, and ensuring activities comply with GMP and regulatory requirements.
Key Responsibilities
- Assist with the preparation, execution, and reporting of cleaning validation studies.
- Perform and coordinate equipment swabbing and rinse sampling activities.
- Work on the manufacturing floor to collect samples from equipment associated with clinical studies.
- Prepare and revise validation protocols, reports, risk assessments, and related documentation.
- Collect, review, organize, and trend cleaning validation data.
- Evaluate validation results against established acceptance criteria.
- Support periodic reviews of cleaning validation programs.
- Assist with investigations related to cleaning validation deviations and excursions.
- Support CAPAs, change controls, and other quality investigations.
- Maintain validation files and ensure documentation is inspection-ready.
- Support FMEA, risk assessments, and gap assessments.
- Assist in identifying worst-case products and equipment locations.
- Coordinate cleaning validation activities with QA, QC, Operations, Engineering, and MS&T.
- Schedule validation activities around manufacturing operations.
- Support continuous improvement of cleaning procedures and validation practices.
- Ensure compliance with cGMP, GMP/GLP, and applicable Canadian, U.S., and EU regulatory requirements.
- Perform other related duties as required.
Required Qualifications
- Bachelor's degree in Science, Engineering, Pharmacy, or a related discipline.
- Minimum 1 year of relevant pharmaceutical industry experience, preferably involving clinical studies or pharmaceutical manufacturing.
- Experience or working knowledge of cleaning validation is preferred.
- Strong English communication skills.
- Proficiency with Microsoft Word and Excel; experience with PowerPoint and Outlook.
- Ability to work with applicable validation, quality, and laboratory software/systems.
- Working knowledge of GMP/GLP, regulatory requirements, WHMIS, and safety procedures.
- Knowledge of pharmaceutical manufacturing and packaging processes is preferred.
- Strong organizational and time-management skills with the ability to manage multiple priorities.
- Willingness to travel occasionally to other company sites.
Day-to-Day Responsibilities
- Creating and updating validation reports and protocols.
- Supporting swab selection activities.
- Working on the manufacturing floor to swab equipment associated with clinical studies.
- Collecting and organizing cleaning validation data.
- Supporting validation investigations and documentation.
- Coordinating activities with cross-functional teams.
Compunnel Inc. is an Equal Employment Opportunity (EEO) employer committed to fostering an inclusive, diverse, and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, citizenship status, age, disability, protected veteran status, marital status, genetic information, or any other characteristic protected by applicable federal, state, or local law.
As a global workforce solutions provider, Compunnel values diversity of thought, background, and experience, and believes an inclusive workforce strengthens innovation and client success.
