cGMP Validation Engineer - Diagnostic Kits Manufacturing - Gaithersburg, MD

Description Seeking biopharma process and lab validation experience and technical Bachelors degree in individiual with thorough knowledge of cGMPs, FDA and pharmaceutical industry guidelines related specifically to Manufacturing Process Validation; Cleaning Validation; Equipment, Facilities and Utilities Validation; Laboratory Equipment Validation; and Control Systems Software Validation.

Key Activities:

• Oversee validation of manufacturing processes, cleaning processes, new equipment, laboratory instrumentation, software, changes and on-going review and revalidation.
• Verify compliance of validation documentation with plant, corporate and regulatory requirements.
• Collaborate with audit teams during audits and inspections.
• Present and defend validation program to regulatory agents and inspectors.
• Provide expert support to development of Standard Operating Procedures and to plant and corporate policy writers on new and revised validation guidelines, specifications and policies.

Join a company w the projects are diverse and exciting, w you can use your expertise to better yourself and your team, and you can meet with upper management to discuss ongoing or future projects. Competitive compensation with salary commensurate with experience and annual performance bonus potential. For complete details contact Christopher Moreno at: (609) 584-9000 ext 264 Or submit resume online at: http://dmc9/cam/app.

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