Validation Engineer Lead
3 days ago
The Automation Engineer SME will be responsible for:
- Configuring and programming biopharma manufacturing equipment used in both upstream and downstream processes, as well as QC lab and analytical equipment.
- Leading the development and execution of validation protocols for computerized equipment.
- Providing expert guidance to internal validation teams.
- Developing and authoring detailed equipment administrative procedures and Standard Operating Procedures (SOPs) related to equipment configuration, calibration, and maintenance.
- Performing and overseeing the execution of validation tests to ensure compliance with regulatory and industry standards.
- Collaborating with validation professionals to ensure alignment and clarity in the development of validation protocols.
The ideal candidate will have a strong background in engineering or life sciences, who has experience in leading validation protocol development and providing expert guidance on computerized systems.
The successful candidate will also have a minimum of 5-7 years' experience in configuring and validating biopharma manufacturing and QC lab equipment, as well as a proven ability to lead and provide expert guidance on validation protocol development for computerized systems.
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