Facilities Engineer

NITTO DENKO Avecia - Milford, MA (30+ days ago)3.0

Full-time

Purpose of the Position:
This position, with general guidance, provides troubleshooting of operational issues in the manufacturing, maintenance or capital projects environment utilizing engineering principles. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.

Key Job Responsibilities:
Maintains clean utility systems to include RO and USP water

Manage ACN, Toluene, N2 and waste systems

Act as the lead on equipment investigations, conducting formal root cause investigations and generation of supporting documentation as appropriate

Coordinate, perform and/or oversee technical facilities project work and equipment installations and validations including writing URDs, Commissioning, IQ and OQ documentation for facilities equipment

Responsible for continuous improvement efforts related to equipment and facilities

Execute projects with minimal supervision

Lead efforts with Manufacturing, Process Development, Facilities, Quality Assurance and other departments in developing requirements and recommendations for system modifications

Execute tasks under the general direction of project managers to complete design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints

Interface with equipment vendors and support contractors

Supports the creation and/or revision of Equipment SOPs and PIs including operation, maintenance, and cleaning procedures, as well as other related documents

Support preventive maintenance and calibration of equipment and systems

Partner with peers, team members, direct and indirect management chain to ensure the following: training plan execution, ensure inspection readiness of assigned areas, participate in timely completion of investigations, deviations and CAPA, provide support for documentation changes, develop and manage change controls

Assist in identification and procurement of spare parts and inventory control

Job Knowledge Required:
A Bachelor’s degree in engineering is required

5-7 years of relevant work experience with 3+ years of experience in API/Bio-Pharmaceuticals

Direct experience within regulated environments (i.e. cGMP, OSHA, EPA)

Prior experience in project management of equipment installations

Thorough understanding of the key elements of process generation equipment to include but not limited to: electrical systems, HVAC, Purified Water systems, controls, chemical handling and safety

CAD experience a plus

General understanding and wide application of technical principle, theories, and concepts in the API/biotech/pharmaceutical field Ability to train and mentor Facilities Technicians

Equal Opportunity Employer