Specialist Engineering, Maintenance, and Utilities

Job Description

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

The Specialist is an individual contributor.

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 area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or 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 and facility improvements and troubleshoot process 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 to ensure supply of a high quality product.

DUTIES

• Works with Operations, other EM&U engineers, Technology, 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 your area 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 bi-annual shutdowns.

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

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

• Identifies 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.

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

QUALIFICATIONS:

Required

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

• 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).

Preferred

Mechanical or Electrical Engineering background.

Previous Pharmaceutical Industry experience.

Pumping and Piping experience.

Familiarization with Industrial Utility Systems.

Packaging experience.

Experience working in a Union environment.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national