What are the responsibilities and job description for the Cleaning Validation Specialist position at ACL Digital?
Job Title: Validation Engineer/Cleaning Validation
Location: Holly Springs, NC
Duration: 1 year contract
Description:
Cleaning Validation Specialist I
Ideal Candidate: 5 YOE with a B.S. in Science, Engineering, and Pharmacy areas.
Standard Hours - hours may vary to support manufacturing (early/later shifts, possible weekends)
Top 3 Must Have Skill Sets:
• Proficient with KNEAT or similar programs.
• 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.
Nice to have: project management experience,
Job Description
Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.
• 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.
• 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.
Basic Qualifications
Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience