Engineering Maintenance Utilities - QLO Lab Support

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

ACCOUNTABILITY

Under the supervision of a Senior Specialist or Associate Director, is responsible for providing technical manufacturing support in the field of engineering, maintenance, and utilities (EMU). Provides day-to-day engineering support for assigned Lab area, along with their associated mechanical support utilities including power, HVAC, steam, WFI, and Controlled Temperature Units. Assigned tasks include support and monitoring of equipment performance and maintenance, propose & develop equipment, facility improvements and troubleshoot lab/lab support equipment to ensure reliable, compliant, and efficient operations. Actively ensures GMP quality, safety, environmental, and operating cost goals are achieved. On occasion, may provide supervisory coverage (for maintenance mechanics) to ensure supply of a high-quality product.

Position Responsibilities:

• Works with Lab OPS, other EM&U engineers, Technology (ESG), Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations.

• Champions the preventive and predictive maintenance program within areas of responsibility, reviews equipment history for reliability concerns, performs root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs.

• Develops maintenance and repair strategy for periodic shutdowns of lab support and utility systems.  Coordinate with maintenance schedulers and manager to schedule and execute shutdown activities.

• Assists/leads Lab OPS, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating Lab atypical events related to equipment/system failure or malfunction.

• Acts as contractor liaison, for contract resources performing work on equipment in areas of responsibility.  This would include ensuring that contract resources perform work in a safe and compliant manner, and that all work is properly documented.

• Serves as the project engineer and manager for small projects including scope development, design support, field execution and commissioning/qualification testing of assigned equipment.

• Collaborate with the Planning group, to identify spare parts and stand-by equipment needed to assure maximum capacity and reliability.

• Supports maintenance scheduling and planning processes in area of responsibility.

• Supports positive safety culture and participates in HAZOP reviews and Safety inspections. Promotes open communications, inclusion, and teamwork.

• Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors.

• Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan.

• Explains and enforces all GMPs, safety, and environmental regulations.  Manages all safety permitting requirements, during the execution of maintenance activities, on Lab, Lab support and Utility systems.

• Assist in audits, regulatory inspections, and training, in the area of responsibility.

Education Minimum Requirement:

• B.S. Engineering, Science, or 4 Year Engineering Technology Degree.

Required Experience and Skills:

• Minimum of three (3) years of manufacturing experience or technical support group or equivalent.

• Proficient in the following competencies: empowering leadership, flexibility, motivation, teamwork/collaboration, problem-solving, communication, and computer skills.

• Knowledge in the application of engineering standards (i.e. ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI).

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

VETJOBS

MMD

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical p