Cleaning Validation Specialist

Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.

Responsibilities

Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies; Supports non-traditional work schedule based on project and business needs; Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program; Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages; Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process; Proficient with KNEAT execution; Design and develop cleaning procedures for new products and manufacturing equipment; Conduct cleaning validation studies, including sampling, testing, and data analysis; Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures; Supports the periodic review of cleaning validation studies; Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises; Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan; Trains manufacturing and QC/QA personnel on cleaning validation documentation

Requirements

Bachelor's in Science, Pharmacy or Engineering; Strong understanding of GMPs and global regulatory expectations; Ability to interpret equipment design, P&IDs, and process flow diagrams; Excellent technical writing and documentation skills; Strong analytical and problem solving abilities; Effective communication and cross-functional collaboration; Ability to work independently and manage multiple priorities; Proficient with KNEAT; Willing to provide services during non-administrative hours based on project needs

Nice to have

Minimum of 5 years of professional experience in cleaning validation in the pharmaceutical and biotechnology industries; Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes; Validation Sample Management lifecycle experience; Strong project management skills; Proficient time management skills, planning and organization capabilities; Proven leadership & teamwork skills, self-starter, results oriented and build and maintain strong relationships with multiple groups; Proficiency in Risk Assessment/Management; Proven assessment, analytical and problem-solving skills; Proficient presentation skills and Technical Writing/Oral communication skills (English); Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry

Benefits

Medical, dental, and vision care; comprehensive suite of benefits focusing on physical, emotional, financial, and social wellness; support for working families (backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, paid caregiver leave); training programs; professional development resources; mentorship programs; employee resource groups; volunteer activities