Engineering Validation Manager
- The position will provide validation support for all cGMP/GLP equipment, instrumentation, facilities and utilities at the Sanford site related to the manufacture of biological drug substances and drug substance intermediates.
- The position leads and/or participates in the planning, preparation and execution of validations for cGMP/GLP equipment, instrumentation, facilities and utilities. This includes generation and execution of protocols, performing routine re-qualifications, maintaining the site validation master plan, troubleshooting problems related to GxP operations, accessing the impact of change to qualified systems and interacting with regulatory authorities during audits.
- At a minimum, the position should be able to execute work independently, work with various groups across the organization and be able to oversee and lead projects to ensure that cGMP/GLP equipment, facilities and utilities perform as intended.
- In addition, knowledge of electronic systems including PDOCs, LIMS, SAP, MS Word and MS Excel is required as part of the job.
Lead validation activities for capital and non-capital projects, including:
- Validation master planning
- Generation of qualification/verification protocols
- Execution of qualification/verification protocols
- Final Report writing for qualification/verification protocols
- Supervision and direction of others performing this work
- Perform routine re-qualification activities Maintain Site Validation Master Plan Support regulatory audits through the preparation, defense and interaction with auditors in areas related to equipment, instrumentation, facilities and utilities
- Provide expertise for trouble-shooting and resolution of issues related to equipment, instrumentation, facilities and utilities Assess potential impact of changes to qualified systems
- Identify and implement validation best practices to continuously improve the site validation program Represent engineering validation on site or network teams as necessary
- The position requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, and area management up-to-date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.
- A minimum 7 years of experience and a Bachelor's degree in any of the following disciplines: Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline is required
- A minimum of 4 years of experience and a Master's in any of the following disciplines: Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline is required.
- Direct knowledge and experience in equipment/utility qualification or verification within a biopharmaceutical or pharmaceutical cGMP environment is preferred.
- Experience with FDA and EU licensing and inspection is preferred.
- Experience with project management is preferred.
- Additional experience in other areas of validation, particularly verification, is preferred.
Position requirements are typical for an office-based work environment with some shop floor exposure. There are no unusual physical or mental requirements for this position.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Schedule is primarily day shift but may require off-shift work on occasions. The position may require working on the floor in manufacturing areas at times which will require a focus on safety. Aseptic gowning could be required.
Other Job Details:
Last Date to Apply: August 11th, 2021
Eligible for Employee Referral Bonus
Eligible for Relocation Assistance