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Automation Expert SME
1 week ago
We are seeking a highly experienced Automation Engineer SME to join our team at Réalta Technologies. The ideal candidate will have hands-on experience in configuring, validating, and programming biopharma equipment.
The Automation Engineer SME will provide expert guidance to internal validation teams and lead the development and execution of validation protocols for computerized equipment. This includes configuring and programming biopharma manufacturing equipment used in both upstream and downstream processes, as well as QC lab and analytical equipment.
- Biopharma Equipment Configuration:
- Configure and program biopharma manufacturing equipment used in both upstream and downstream processes, as well as QC lab and analytical equipment.
- This includes but is not limited to: bioreactors, TFF Systems, Chromatography Systems, Balances, Flow Instruments (FITs), Cell Counters.
The successful candidate will also lead the preparation, review, and execution of critical documents such as User Requirement Specifications (URS), Functional Design Specifications (FDS), System Design Specifications (SDS), Hardware Design Specifications (HDS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ).
In addition, the Automation Engineer SME will perform and oversee the execution of validation tests to ensure compliance with regulatory and industry standards. They will collaborate with validation professionals to ensure alignment and clarity in the development of validation protocols.
The role also involves developing and authoring detailed equipment administrative procedures and Standard Operating Procedures (SOPs) related to equipment configuration, calibration, and maintenance.
We are looking for a candidate with a strong background in engineering or life sciences, who has experience in leading validation protocol development and providing expert guidance on computerized systems.
The ideal candidate will 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.
