Company: Renaissance LLC
Posted on: January 22, 2023
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
The Project Engineer is responsible for managing construction and
engineering projects in a cGMP environment through planning,
organizing, and controlling all elements of the project. Have the
ability and competency to oversee all facility and utility upgrade
projects, inclusive but not limited to area renovation, new cGMP
manufacturing suites, and purchase of new manufacturing equipment.
Apply engineering principles to support operational initiatives
such as equipment reliability enhancement, environmental
sustainability, project execution standardization and continuous
improvement. Ability to work in a fast-pace environment and the
competence to concurrently handle multiple projects and operational
initiatives. This position is exempt from overtime.
Manage small, medium, and large projects from requirement
specifications & design to implementation and validation phases
--- Drive and ensure compliance with all federal and state
regulations, including OSHA, DEP, EPA, FDA.
--- Create detailed project plans and schedules using MS Project to
drive successful project outcome, while driving accountability.
--- Prepare project support documentation, including: project
scopes, presentation of conceptual designs, capital requests,
purchase orders, project plans and schedules, user/functional
specifications, design specifications, piping and instrumentation
diagrams, process flow diagrams, start-up and equipment operational
procedures and commissioning.
--- Control project cost by ensuring robust contractor agreements
are in place, prior to commencing any work, and by closely
monitoring and approving capital expenditures.
--- Prepare and review contractor bids, interviews and vendor
--- Ensure appropriate communication to all project stakeholders
through meetings, project reports, and other forms of
--- Design and specify HVAC systems and other utility solutions
(WFI Water, Compressed Air, Vacuum, Clean Steam, Nitrogen, etc.) in
support of manufacturing, packaging and laboratory spaces.
--- Knowledge of cGMP manufacturing space construction in
compliance with ISO 14644 Cleanroom standards.
--- Knowledge of Building Management Systems and Computerized
Maintenance Management Systems.
--- Perform design review for all construction related designs:
mechanical, electrical and plumbing.
--- Assist in the design review, factory acceptance, site
acceptance, installation of equipment, as well as equipment
--- Evaluate equipment performance and provide improvement
recommendation for equipment optimization, while ensure safe
--- Support compliance activities, such as change control,
deviation management and CAPA resolution
--- Assist in investigations of facility equipment, utility
systems, and control anomalies as well as safety incidents.
--- Write and modify procedures for the proper operation of new
and/or existing equipment.
--- Assist in equipment transition from validation to
commercial/developmental line use
--- Propose and implement operational efficiency improvements for
facility and utility systems.
--- Assist with training of operations and maintenance personnel,
--- Perform other duties and responsibilities as assigned.
B.S. degree in Mechanical, Electrical Engineering is required. 3 to
7 years of relevant experience in the pharmaceutical industry and
PMP certification is a plus.
--- A thorough knowledge of construction in a cGMP environment,
HVAC design and controls requirements.
--- Advanced knowledge of engineering documentation required for
cGMP processing and substantial knowledge of cleanroom design and
--- Extensive knowledge of project management, utilizing PMO
Keywords: Renaissance LLC, Lakewood , Project Engineer, Engineering , Lakewood, New Jersey
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