Sr. Facility Operations Engineer (Pharma/CDMO Facility)

Porton Pharma Solutions Ltd.; Cranbury Township (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Sr. Facility Operations Engineer to ensure the smooth operation of their pharmaceutical facility. This role involves managing equipment maintenance, coordinating with scientific teams, and ensuring compliance with GMP regulations. The ideal candidate will have extensive experience in facility operations and a strong background in laboratory equipment. Join a dynamic team that values quality and safety, and contribute to critical projects that make a difference in the pharmaceutical industry. This position offers a chance to work in a collaborative environment where your expertise will be highly valued.

Qualifications

• 5-15 years of experience in facilities and laboratory equipment support.
• Proven track record of meeting aggressive targets in a GMP environment.

Responsibilities

• Oversee maintenance and repair of lab and facility equipment.
• Coordinate with teams for equipment moves and installations.

Skills

GMP operations

Troubleshooting

Field maintenance

Communication skills

Project management

Microsoft Office

Education

Bachelor’s in Chemistry or Engineering

Tools

HVAC systems

BAS IVu

GMP circulator chillers

Rotary evaporators

Chromatography systems

Job description

Sr. Facility Operations Engineer (Pharma/CDMO Facility)

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Job Title: Sr. Facility Operations Engineer

Reporting line: Director or above

Primary Location: Cranbury, NJ, USA

Job Type: Full Time Onsite

Prerequisites

• Bachelor’s in chemistry or engineering-related field is preferred but not required.
• >5-15 years of proven facilities and laboratory equipment, instrument and controls technical support experience is required.
• Experience within the pharmaceutical/biotechnology industry or CDMO industry is desirable but not required.

Responsibilities

• Perform all the duties of Facility Operations Engineer 1 with a higher level of expertise and experience in GMP operations, supervision, troubleshooting and field maintenance repair skills.
• Responsible for asset tagging and maintaining accurate and up-to-date records of all equipment and instrumentation at J-Star facilities.
• Manage equipment and parts inventory storage areas and distribution/allocation of equipment across company facilities.
• Coordinate and participate in periodic physical inventory of equipment and instrumentation that maps to location and internal asset ID number.
• Partner with Scientific Staff, Facility Operation Management to oversee equipment and instrument moves and new installations at J-star facilities.
• Responsible for the routine maintenance and repair, qualification support of the portfolio of lab and facility equipment which includes but is not limited to HVAC systems, BAS IVu, GMP circulator chillers, rotary evaporators, jacketed vessels, thermocouples, digital controllers (temperature and vacuum), vacuum pumps, vacuum ovens, sonicators, chromatography systems (ISCO and Biotage), freeze dryers/lyophilizers, centrifuges, and other equipment as appropriate.
• Coordinate and partner with designated single-point-of-contact (SPOC) for routine maintenance, upkeep and repairs of facility and lab equipment and instruments which include but is not limited to particle size reduction equipment, spray dryer, and other equipment as appropriate.
• Monitor, track and coordinate all corrective and preventative maintenance work activities for analytical and facility equipment and instrumentation.
• Inspect/review outside contractor work related to equipment and instrumentation and provide internal confirmation of successful completion to internal accounts payable department.
• Repair and maintain kilo-lab specific equipment at company facilities.
• Work with Analytical/QC/QA management, IT manager, and 3rd party IT company to ensure appropriate GMP and non-GMP non-analytical instrument/equipment IT connectivity, integration and data archival and backup at company facilities.
• For select, designated equipment, instruments, and kilo lab equipment, maintain records for use and clean out, as appropriate.
• Minimize reliance on outside third-party vendors and perform basic maintenance and repairs on equipment and instrumentation.
• Participate as necessary in equipment and instrument IQ, OQ and PQ at company facilities.
• Take lead or act as SPOC with outside vendor for production/processing equipment and non-analytical instrumentation repairs and modifications as needed in alignment with internal stakeholder needs.
• Maintain operations related to all equipment and instrumentation and ensure work is performed in compliance with all state and federal guidance and regulations, including but not limited to GMP, DEA, EPA, FDA, OSHA, etc.
• Contribute to site readiness in advance of 3rd party site audits and inspections.
• Maintain an uncompromising focus on quality, GMP documentation, confidentiality and technical execution.
• Contribute to writing and editing SOPs and SOGs as appropriate.
• Contribute to writing and editing preventative maintenance protocols as appropriate.
• Ensure proper disposal of equipment and instrumentation.
• Maintain appropriate asset system updates and asset tagging when new equipment is purchased, existing equipment is relocated, or existing equipment is abandoned.
• Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines, SOPs and Chemical Hygiene Plan CHP(s). Actively participate in EHS discussions with company stakeholders and management for continuous improvement of EHS practices.
• Manage and track relevant company equipment and instrument service agreements.
• Perform other job-related duties as assigned by Facility Operation Director.

Qualifications

• Proven track record of setting and meeting aggressive targets related to safe, timely execution of objectives.
• Excellent written, verbal and communication skills.
• Ability to prioritize and manage numerous projects simultaneously.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Ability to communicate candidly, clearly and timely.
• Experience in working on and positively contributing to teams.
• Proficient in MicrosoftOffice and other job-related software and applications.
• Ability to perform the physical requirements of the position. Must be able to walk, stand, crawl, stoop, crouch, bend or reach above and below shoulders height frequently. This job requires frequent twisting and turning of the body and the use of both hands.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Engineering, Manufacturing, and Strategy/Planning

Industries

• Pharmaceutical Manufacturing

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