ENGINEERING & FACILITIES MANAGER

REQUIRES 7+ YEARS OF RELEVANT INDUSTRIAL EXPERIENCE WITH AT LEAST 4+ YEARS OF EXPERIENCE IN PHARMACEUTICAL, BIOTECH, MEDICAL DEVICE, OR RELATED INDUSTRY!

BS degree in engineering discipline required - Mechanical or Electrical Engineering preferred.  MS in engineering discipline or MBA a plus. 

Demonstrated experience designing engineering and maintenance processes and systems in existing operations as well as for new facility startups.  Previous supervisory experience preferred.  Additional broad based background in several of the following preferred:  API manufacture, component/equipment prep, filter prep, buffer prep, high speed filling, lyophilization, and label/pack. 

Understanding of utilities such as HVAC, BAS, Air Handlers, Compressed Air, and Clean Water Systems required.  Hands-on experience with, CIP, SIP and pharmaceutical process equipment.  Experience with validation, including protocol development, execution, final reports, temperature mapping, discrepancy resolution and SIP validation. Familiarity with Design, test and start-up PLC programs, SCADA interfaces, and integrated systems.

The candidate will have demonstrated experience in managing projects and must have strong leadership ability, having successfully led projects, teams, and/or direct reports.  Ability to communicate with confidence to multiple levels is required.  Strong influencing ability, business acumen, and motivation are highly desired.  Ability to use AutoCAD, Excel and MS Project as business tools preferred.  Strong problem solving and technical writing skills desired.

Summary:

This lead position will be responsible for managing the Engineering and Facilities programs that support manufacture of API and Drug Product in two GMP manufacturing facilities.  The successful candidate will be comfortable in a fast-paced entrepreneurial environment and will be able to implement best-in-class engineering and maintenance processes and controls. This position will interact with internal and external clients and will serve as a subject technical lead. The position reports to the site Director of Operations.  This role will require approximately 5% travel per year.

 

Essential Functions:

§Manage the preventive and corrective maintenance of equipment, machinery, buildings, structures, and utility systems for two manufacturing facilities.

§Manage the Calibration program.  Implement a capital asset management program.  Implement an equipment nomenclature/numbering system. 

§Negotiate contracts and manage contract services and vendors.

§Direct office and space planning.

§Coordinate with EH&S, QA, Operations, and Validation groups for project design, project management and financial management of facility and equipment projects.

§Assure that value engineering, constructability reviews and similar processes are effectively utilized to minimize capital expenditures and maximize functional values.

§Develop and manage capital and expense budgets.  Perform variance reporting.

§Assist in the planning, design, implementation, and administration of the building automation systems including automation controllers, servers, networking, links to manufacturing automation, alarm management and data management. 

§Work closely with technicians to trouble shoot HVAC control system problems and with the IT group for server and telecommunications operations support.

§Write and summarize detailed technical engineering reports.

§Prepare for Pre-Approval Inspection.  Prepare for and participates in regulatory audits.

§Ensure workplace safety and security within OSHA, EPA and all applicable governing body standards across manufacturing areas.  Assure compliance with good engineering practices, cGMP, and other related codes/regulations.

Submit resumes:

biologicshr@mentorcorp.com

www.mentorcorp.com

EEO M/F/D/V