MV01-041026 Cleaning Validation Specialist

MV01-041026

Cleaning Validation Specialist Apex, NC Job Details Full-time 1 day ago Qualifications OSHA (regulatory compliance area) Biotechnology Pharmaceutical regulatory compliance English GMP Technical report writing Continuous improvement FDA regulations Engineering validation Full Job Description Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

Cleaning Validation Specialist Responsibilities:

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. Provide technical support and sample management to cleaning activities associated with the manufacturing process. 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.

Qualifications:

Bachelor's in science, Pharmacy or Engineering or 8 plus years in pharmaceutical industry with hands on Cleaning Validation experience. Proficient execution experience in Kneat 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. Available to work extended hours, possibility of weekends and holidays. At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Excited to build something meaningful together? We look forward to hearing from you. Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. #LI-LN1 #ONSITE