Specialist, Engineering

Job Description

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.

Shift: 2nd Monday-Friday 3pm-11pm

Essential:

• 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:

• 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). Computerized Management Maintenance Systems SAP), and CMRP certification desired.

Note:    This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.

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