Senior Validation Engineer

Senior Validation Engineer


Senior Validation Engineer

Details of the offer

Responsible for the development, execution, review and coordination of validation activities including, commissioning, qualification, and validation (CQV) of facility, utilities, manufacturing process equipment, and cleaning validation for product manufacturing facilities.

Essential Duties and Responsibilities
Generate protocols and perform execution in the following validation areas; Temperature mapping of warehouses and temperature controlled chambers. Aseptic manufacturing equipment IQ and OQ Non:sterile manufacturing equipment IQ and OQ Utility system IQ and OQ Laboratory equipment IQ and OQ Automated systems qualifications Sterilization process PQ (Autoclaves, Dry Heat Ovens, Process SIP, VPHP) Cleaning validation (CIP/COP) Aseptic media simulations Product Process Validation Responsible for the change management for validated processes and equipment. Prepare and maintain site and project Validation Plans. Maintain and manage re:qualification schedules. Plan and coordinate specific validation activities for projects. Provide validation input to Engineering and Maintenance in equipment purchase requirements. Interface with Engineering, Facilities, Regulatory, and Manufacturing personnel as needed. Review and approve cycle development initiatives and activities. Perform other related duties as assigned.
Knowledge, Skills and Abilities
Experienced with validation tools such as Kaye Validator. Proficient knowledge and experience in writing validation protocols and reports Proficient knowledge of GMP and EU regulations related to validation including ISPE and PDA guides. Good technical skills and the ability to understand technical documentation such as equipment manuals or drawings. Knowledge of risk based approach for validation Ability to maintain gowning requirements as needed to access controlled areas Effective organization and project management skills. Effective troubleshooting and problem solving skills. Ability to manage multiple projects simultaneously. Ability to work effectively both independently and in conjunction with a team. Develop and implement creative solutions to problems. A valid drivers license and acceptable motor vehicle record required. Ability to train junior associates in validation principles.
Education and Experience
Bachelors degree in Engineering or Science related field. Five or more years experience in the pharmaceutical industry, minimum four years in validation required. Demonstrated experience in four or more validation areas.
Working Conditions
Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work. Work inside manufacturing clean rooms where gowning is required. Qualifications Education

Bachelors or better in Engineering or related field.

Experience in four or more validation areas.

5 years: Experience in the pharmaceutical industry, minimum four years in validation required.

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