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DATE ADDED: Wed 03/10/2018

Facilities Project Engineer - Cleanroom Experience Required

Lakewood, USA
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COMPANY: RENAISSANCE PHARMACEUTICALS

Job Description

Renaissance Pharmaceuticals markets high-quality pharmaceuticals that fulfill patient needs.

Renaissance recognizes that patient care relies on quality pharmaceutical drugs that have gained the confidence of health care professionals. We are building a specialized portfolio of pharmaceutical products that you can trust to be time-tested, safe, reliable and proven.

With decades of experience, our Lakewood, New Jersey, facility is well-equipped to develop and manufacture a broad range of sterile and/or environmentally controlled products. From early-stage development through final production, Renaissance has the expertise and resources you need for success.

We are currently searching for two Project Engineers in Lakewood, NJ who will be responsible for managing construction and engineering projects in a cGMP environment through planning, organizing and controlling all elements of the project. You should have the ability and competency to oversee all facility and utility upgrade projects. You will apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. You must have the ability to work in a fast-pace environment and the competence to concurrently handle multiple projects and operational initiatives. 

Responsibilities

•        Manage small, medium to large facility 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 using MS Project to drive successful project outcome, 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 selection.

•        Ensure appropriate communication to all project stakeholders through meetings, project reports, and other forms of communication.

•        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.

•        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 qualification

•        Evaluate equipment performance and provide improvement recommendation for equipment optimization, while ensure safe operation.

•        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.

•        Propose and implement operational efficiency improvements for facility and utility systems.

•        Assist with training of operations and maintenance personnel, as needed.

Qualifications:

•        B.S. degree in Mechanical or Electrical Engineering

•        3 to 7+ years of relevant experience in the pharmaceutical industry

•        Extensive knowledge of project management, utilizing PMO standards - PMP certification is a plus

•        Knowledge of cGMP manufacturing space construction in compliance with ISO 14644 Cleanroom standards.

•        Extensive knowledge of Building Management Systems (BMS) and Computerized Maintenance Management Systems (CMMS).

•        A thorough knowledge of construction in a cGMP environment, HVAC design and controls requirements.

•        Advanced knowledge of engineering documentation required for cGMP processing and knowledge of cleanroom design and operation

To join our dynamic, exceptional team, please visit our website or submit your resume here.

EOE

 

Company Description
Renaissance Pharmaceuticals markets high-quality pharmaceuticals that fulfill patient needs.

Renaissance recognizes that patient care relies on quality pharmaceutical drugs that have gained the confidence of health care professionals. We are building a specialized portfolio of pharmaceutical products that you can trust to be time-tested, safe, reliable and proven.

With decades of experience, our Lakewood, New Jersey, facility is well-equipped to develop and manufacture a broad range of sterile and/or environmentally controlled products. From early-stage development through final production, Renaissance has the expertise and resources you need for success.


Role: Facilities Project Engineer - Cleanroom experience required
Job Type:
Location: Lakewood,

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