ApTask Global Workforce (AGW) is seeking a Validation Engineer with a technology company. This is a 12+ month contract opportunity with our client located in Holly Springs, NC. Summary: This role supports the execution and management of the Cleaning Validation (CV) lifecycle. The ideal candidate will coordinate cleaning validation activities, prepare and execute protocols and reports for cleaning development and validation, and provide technical support to cleaning activities associated with the manufacturing process. This position may require a non-traditional work schedule, including early or later shifts and possible weekends, to support manufacturing needs.
Responsibilities: - Coordinate cleaning validation activities
- Support authoring and executing CV/CHT/SHT protocols, progress package work, and wrap up executed studies
- Lead and perform on-floor CV execution and sampling
- Provide technical support and sample management to cleaning activities
- Design and develop cleaning procedures for new products and manufacturing equipment
- Investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations, and out-of-specification results
- Support the periodic review of cleaning validation studies
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering
- Train manufacturing and QC/QA personnel on cleaning validation documentation
Requirements: - Master's degree OR Bachelor's degree and 2+ years of experience OR Associate's degree and 6+ years of experience OR High School diploma/GED and 8+ years of experience
- Ideal candidate will have 5+ years of experience with a B.S. in Science, Engineering, or Pharmacy
- 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
- Familiar with Drug substance process equipment, autoclaves, parts washers, and CIP skids
- Demonstrated proficiency in utilizing PI for run trending analysis
Desired skills: - Project management experience
Pay range: Up to $ 47.62 per Hour
Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.
If you have the described qualifications and are interested in this exciting opportunity, please apply! ApTask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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