• Experienced with management of equipment procurement process and aids in identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories with respect to testing standards.
• Design and execute qualifications, requalifications and process validations of M&TE as required by appropriate Biotech and Pharmaceutical industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025, etc.).
• Analyze qualification, requalification and validation raw data and generate final reports.
• Work with IT to ensure equipment that generates electronic data is complaint with 21 CFR Part 11.
• Investigate and troubleshoots using advanced mathematical and engineering knowledge.
• Complete nonconformance, corrective action and preventative action documentation.
• Prepare, review and maintain written technical documents for M&TE, including protocols, reports, Standard Operating Procedures (SOPs) and Equipment Operating Procedures (EOPs).
• Perform raw data review for qualifications, calibrations, and equipment service.
• Write and implements change control plans and risk assessments.
• Experienced with coordinating and documenting scheduled/unscheduled maintenance of equipment.
• Experienced and possesses technical aptitude required for requalifying, conducting process validations and trouble-shooting sterilizers and resistometers.
• Experienced with driving purchasing process for materials/services needed for owning departments.
• Maintain and support equipment documentation in the Equipment Management System.
• Provide training on equipment use to laboratory and support staff.
• Drive trending and analysis of TE failures.
• Experienced with installing, qualifying and maintaining Siemens monitoring points.
• Assists laboratory personnel with continuous monitoring and alarm investigations.
• Administrate and performs maintenance and upgrades of engineering software systems.
• Create and maintain Associate user accounts to all Engineering systems.
• Responsible for writing and executing building expansion validations.
• Updates/Maintains Engineering drawings for buildings, equipment and system.
• Update and maintains Engineering drawings for buildings, equipment and systems.
• Provide equipment records to appropriate staff as needed for client audits and acts as qualification/validation SME where appropriate.
• Train Associates on new and existing equipment and processes.
• Apply standard engineering techniques to improve various processes and assists the laboratories with identifying equipment needs for proactive planning.
• Ensure electronic and paper equipment files are retired/archived appropriately