Validation Lead
- Job Title
- Validation Lead
- Job ID
- 27709865
- Location
- Mainland, PA
- Other Location
- Description
-
Validation Lead, Full Time.
Accupac is hiring a full-time Validation Lead to join our 1st shift team at our Mainland PA. Location.
The Validation Leads basic job functions include but are not limited to. All validation activity along with managing all aspects of equipment maintenance and calibration, including laboratory instrumentation. The Validation Supervisor 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:- Creates, revises, reviews and approves all validation protocols.
- Maintains the Site Validation Master plan and subsequent validation master plans.
- Assist with purchasing of new manufacturing, packaging, and laboratory equipment.
- Set up and maintains vendor calibration and maintenance contracts.
- Maintain the Company’s compliance with established Accupac, Inc. Standard Operating Procedures, FDA Current Good Manufacturing Practices and the Customer’s specifications. Is capable of interpreting intent and requirements within them.
- Stays abreast of emerging general GMP industry validation trends.
- Assists in training new Validation Associates.
- Perform Equipment Gap analysis.
- Review all questions, errors, and deviations with the respective departmental Management and QA and resolves issues.
- Maintain the completed validation documentation and all associated data.
- Maintain open communication with Project Management for validation requirements.
- Provide oversight on the timely completion of PMs and Calibrations.
- Sets ups vendor calibration contracts.
- Write SOP’s Edit update revise review for validation department and laboratory department.
- Send equipment off site for calibrations or PMs as needed.
- Review 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
- Other duties as assigned.
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
Physical Requirements:- Ability to stand/sit for long periods of time.
- Ability to lift and carry items up to forty (40) pounds.
- Possess peripheral vision.
Supervisory Responsibilities: No
Travel: Occasional
Education and/or Experience: A Validation Lead must have a B.S College degree or previous validation experience. A minimum of 1 years of experience in a cGMP regulated industry and 2 years of experience in validation.
Preferred:- Possess a working knowledge of Liquid/Solid Manufacturing and Packaging Process.
- Experienced with Equipment and Facility Validation protocols and ( IQ/ OQ/ PQ).
#INDOTHER2023
- 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
Physical Requirements:
Ability to stand/sit for long periods of time.
Ability to lift and carry items up to forty (40) pounds.
Possess peripheral vision.