Engineering Validation Associate
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.
Responsibilities include the following:
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 Assist with maintenance of 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.
- BS degree in any of the following disciplines: Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline.
- Direct knowledge and experience in equipment/utility qualification or verification within a biopharmaceutical or pharmaceutical cGMP environment is desired.
- 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 a plus.
- 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 (up to 50%) at times which will require a focus on safety. Aseptic gowning could be required.
Last Date to Apply: 11/3/20
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Quality Assurance and Control