Sr. Tech, Maintenance

Key Duties

• 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
• Perform routine maintenance tasks and troubleshoot complex process systems including process equipment, support equipment, utility equipment, automated systems, Clean-In-Place (CIP) systems, and maintenance equipment
• Develop Standard Operating Procedures (SOPs) and Preventative Maintenance (PM) plans
• Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control activities
• Assist with execution of calibration, automation, validation and additional testing
• Develop and execute engineering change request (ECRs)
• Identify and resolve technical and operational problems; collaborate with peers to resolve cross-unit problems
• Assist in identification, development, and implementation of new systems to enhance operation and/or engineering processes
• Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures
• Order and maintain spare parts for assigned process equipment; ensure inventory transactions are complete, timely, and accurate
• Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems
• Serve as a Subject Matter Expert (SME) during tours and provide training for system maintenance

Quality & Safety Compliance

• Examine issues from safety, compliance, automation, equipment, process, and people perspectives to identify root cause
• Provide input to investigate deviations and interface with approvers
• Wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses
• Clean room gowning during performance of job duties
• Support safety initiatives including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates

Education Minimum Requirement

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).

Required Experience and Skills

• Familiarity of regulatory requirements in accordance with GMP manufacturing operations
• Good oral and written communication skills
• 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 required
• Proficiency in computer systems and applications including Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems
• Effective maintenance, troubleshooting, and problem-solving skills
• Available for On-Call work rotation during off-hours and weekend overtime as needed

Preferred Experience and Skills

• SAP experience related to plant maintenance and spare parts procurement systems
• cGMP experience in a sterile, bulk or finished pharmaceutical environment
• Experience authoring PM/calibration job plans and management of spare parts
• Installation, operation, maintenance and/or troubleshooting experience with biopharmaceutical manufacturing equipment such as washers, autoclaves, skids, tanks, bioreactors, and filtration skids
• Ability to read P&IDs, electrical drawings, blueprints, etc.
• Ability to manage multiple priorities and advance several tasks in parallel
• Knowledge of Allen Bradley PLCs, Siemens Apogee BAS