Sr. Tech, Maintenance

Job Description 03 Production Technician The Senior Tech, Engineering is a member of the Engineering team providing technical support within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. The candidate will support the installation, operation, maintenance and/or troubleshooting of biopharmaceutical manufacturing equipment such as washers, autoclaves, tanks, bioreactors, filtration skids, filling lines, lyophilizers and isolators.

Develops Standard Operating Procedures (SOPs) and Preventative Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team culture including significant interaction with operations, quality, automation, technology, and other groups as required.

Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including but not limited to:
Process Equipment (e.g. Filling Machine, Lophilizer) Support Equipment (e.g. washers, autoclaves, incubators) Utility Equipment (e.g. Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems) Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC)) Clean-In-Place (CIP) Systems Maintenance Equipment (e.g. tools and calibration equipment) Assist with execution of calibration, automation, validation and additional testing, as required Decisions are guided by policies, procedures and business plan;

receives guidance from manager. Contributes to the performance and results of the department. Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units Responsible for assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes. Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

Develop and execute engineering change request (ECRs), as necessary. The successful candidate should be able to examine an issue from perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause. Provide input to investigate deviations, with responsibility to interface with approvers. Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.

Position requires clean room gowning during performance of job duties Actively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates

Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems Support daily meetings to facilitate flow of information up/down through the organization Escalate issues as needed to ensure the right support/awareness is given to issues as they arise Serve as a Subject Matter Expert (SME) during tours to provide area/process overview information to visitors/auditors upon request.

Working as a SME, provide necessary training for system maintenance as needed.

Order and maintain spare parts for assigned process equipment Ensure inventory transactions are complete, timely, and accurate Recognize and communicate opportunities for cost savings

High School Diploma or GED Equivalent, 3 years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems).

Familiarity of regulatory requirements in accordance with GMP manufacturing operations Good oral and written communication skills Physical requirements – Must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling, and stooping is required. Proficiency in computer systems and…