Sr. Equipment Engineer

The equipment engineer must have hands-on experience with laboratory and manufacturing equipment, specifically with autoclaves, fill machine, bioreactors and iCellis.   They will be subject matter expert for all production and laboratory equipment.  The engineer will be responsible for planning, implementing, and maintaining the equipment. They perform analyses of the current maintenance plan and make recommendations for reliability improvements; this includes changes to the preventative maintenance and calibration plans.  The Sr. Equipment Engineer shall assist with technical input for deviations or change controls related to production equipment.  

• Perform routine maintenance and troubleshooting on key equipment, including autoclaves, bioreactors, filling machine and related systems.
• Diagnose mechanical and electrical issues, resolve problems, and ensure equipment is running at optimal performance.
• Provide technical support to operation teams during production and process cycles.
• Develop, implement, execute, coordinate and track preventative and predictive maintenance and calibration programs to minimize equipment downtime.
• Ensure the calibration and validation of laboratory and biomanufacturing equipment meet the GMP regulatory standards and/or manage OEM vendor maintenance and calibrations.
• Monitor and manage equipment lifecycle.
• Identify and manage inventory of critical equipment spares.
• Oversee capital equipment purchase projects in a PM role. Manage timeline and costs in alignment with approved budgets.
• Act as a technical resource for the engineering team and management.
• Enter and maintain work orders and manage equipment history files in BM-RAM.
• Manage equipment under the facilities monitoring system.
• Manage equipment maintenance activities to include orchestration of equipment maintenance and calibration activities during the annual shutdown as well as periodic monthly, quarterly and semi-annual activities.
• Other duties as assigned.

• Bachelor’s in engineering degree with a minimum of 5 years of experience in maintenance, operations or engineering of GMP and Non-GMP production and facility equipment and systems in manufacturing plant or equivalent experience of 10 years of equipment facilities engineering experience with 5 in a pharmaceutical manufacturing environment
• Knowledge of troubleshooting mechanical, pneumatic, & control systems.
• Knowledge on CAD, Visio and software like MS Word, Excel and PowerPoint.
• Experience with CMMS and BMS software.
• Hands-on experience with autoclave, bioreactor and fill machine and other laboratory equipment
• Good writing and communication skills.
• Able to work with minimal supervision.
• Good understanding of validation requirements as defined in the CFR.
• Possess excellent interpersonal skills
• Must be able to communicate effectively with all staff levels.
• Requires knowledge of instrumentation calibration.
• Takes initiative
• Remains calm under pressure
• Possess managerial courage

• Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
• Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.