Summary: Specifies instrumentation for biopharmaceutical process systems and establishes appropriate calibration range and tolerances. Evaluates current instrumentation for reliability and assesses alternative options available. Evaluates new instruments for functional equivalence to existing instrumentation.
Essential Duties and Responsibilities include, but are not limited to, the following:
Lead reliability improvements to identify opportunities in advance to support planned and predictive replacement vs reactive replacement using existing & developing technologies.
Provide support, direction, and subject matter expertise on E&I issues, lead development of site Instrumentation Specifications.
Specifies cGMP process instrumentation, components, and spare parts.
Provide engineering support to maintenance, calibration, and equipment owners for process instrumentation.
Interpret P&IDs, equipment/system layouts, wiring diagrams and specifications in planning and performing maintenance and repairs.
Carry out internal audits and periodic reviews of GMP activities to ensure compliance.
Ensure site instrumentation data integrity standards are in line with regulatory and international standards.
Sets priorities for and completes Calibration Range and Tolerance Justifications forms for new instruments.
Evaluates new instruments for Functional Equivalence to existing instrumentation that has become obsolete.
Conducts troubleshooting and root cause analysis for complex instrumentation and associated systems and recommends corrective actions.
Creates and maintains configuration specifications for cGMP manufacturing equipment.
Assists in the design review of equipment, and approved supplier lists for instrumentation.
Writes and executes test plans and technical evaluations to demonstrate instrument suitability for change control documentation.
Implements corrective/preventative actions for existing equipment.
May supervise engineering contractors and junior team members.
Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
Maintains company reputation by enforcing compliance with regulatory bodies and international standards.
Education and experience:
Requires Level 8 qualification or higher in Instrument Engineering or equivalent with 5+ years of experience in engineering preferred. Direct experience with biopharmaceutical process equipment is preferred.
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