- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy.Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- Our company Manufacturing Division is a team of dedicated,energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant,reliable supply to customers and patients on time, every time,across the globe.
- 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, lab operations, 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 include but are not limited to:
- 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 team work.
- 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.
- In accordance with Policy 82 - 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.
Bachelor’s Degree (Engineering or Science) or a 4-Year Engineering Technology Degree or demonstrated equivalent work experience.
- Proficiency 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).
- Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis.
- Knowledge in reliability engineering (including asset life cycle management) as well as Computerized Management Maintenance Systems (CMMS), SAP, PI, Delta V and BAS.
- CMRP certification.