Process Validation Manager
- Job Title
- Process Validation Manager
- Job ID
- Mainland, PA
- Other Location
Manager, Process Validation, Full Time.
Accupac is looking for a full time Process Validation Manager to join our first shift team at our Mainland PA. location.
Basic Job Functions:
The Process Validation Manager is responsible for all validation activity along with managing all aspects of equipment maintenance and calibration, including laboratory instrumentation. They must have a working knowledge and clear understanding of all validation activities including but not limited to Cleaning, Manufacturing, Packaging, Equipment, Utilities, and Computer Systems.
Essential Functions of the Job:
- This position will provide process validation leadership for packaging processes.
- The position leads and/or participates in the planning, preparation, execution, and summarization of process validation activities.
- The role also provides input into validation assessments supporting investigations, change controls, and periodic reviews associated with the process validation lifecycle for a manufacturing process/product.
- Creates, revises, reviews and approves all validation protocols. Maintains the completed validation documentation and all associated data.
- Maintains the Site Validation Master plan and subsequent validation master plans.
- Assist with purchasing of new manufacturing, packaging, and laboratory equipment. Perform Equipment Gap analysis.
- Set up and maintain vendor calibration and maintenance contracts.
- Maintain the Company’s compliance with established Standard Operating Procedures (SOPs), FDA current Good Manufacturing Practices (cGMP) and customer specifications. Is capable of interpreting intent and requirements within them.
- Review all questions, errors, and deviations with the respective departmental Management and QA and resolve issues.
- Maintain open communication with Project Management for validation requirements.
- Provide oversight on the timely completion of PMs and Calibrations.
- Sets ups vendor calibration contracts.
- Writes, edits, and revises SOPs for the validation and laboratory department.
- Send equipment off site for calibrations or PMs as needed.
- Reviews completed validation, PM, calibration documentation for accuracy and GMP compliance. Performs other related duties as required and assigned.
- Creates, processes, and closes Purchase Orders
- Assist with and leads investigations, ATD’s, CAPAs, and Corrective/preventative maintenance.
- Audits Participate Customer Internal
- Lab CSV Calibrate schedule, PM, Audits
Minimum Requirements of the Job:
- Build relationships with executive stakeholders.
- Provide managerial guidance and coaching to direct reports.
- Effective time management and organizational skills
- Communicate effectively (verbally and in writing) in English.
- Perform mathematical functions and understand metric equivalents of US measurements.
- Possess a working knowledge of Microsoft Word, Windows, Excel, and Power Point
- Comply with all company policies, SOP’s, current Good Manufacturing Practices and other relevant regulatory requirements.
- Able to sit and/or stand for extended periods.
- Able to be able to lift & carry various items up to 20 pounds
Supervisory Responsibilities: Yes
Education and/or Experience:
- Bachelor’s Degree (B.S. or B.A.) in Biology, Chemistry, Engineering or related fields
- Minimum of 4 years of Process Validation experience in a cGMP regulated industry
- Experience managing a team and building key stakeholder relationship
- Working knowledge of Liquid/Solid Manufacturing and Packaging Process (preferred)
- Experienced with Equipment and Facility Validation protocols, Instillation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) (preferred)
- Required Skills
Minimum Requirements of the Job:
Possess effective time management and organizational skills.
Ability to read, write, speak and comprehend the English language.
Ability to perform mathematical functions (add, subtract, multiply, divide and use of percentages) with whole numbers and decimals.
Understand Metric equivalents of US measurements (grams/ounces: kilograms/pounds: liters/gallons).
Possess a working knowledge of Microsoft Word, Windows, Excel, and Power Point
Present a neat and professional appearance that displays confidence and maturity.
Conduct oneself in a professional manner.
Comply with all company policies, SOP’s, current Good Manufacturing Practices and other relevant regulatory requirements.
Maintain training at or above 90% of assigned curriculum.
Attention to detail.
Generate and maintain PO’s
Ability to stand/sit for long periods of time.
Ability to lift and carry items up to forty (40) pounds.
Possess peripheral vision.