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Construction Project Manager - Pharmaceuticals

Location : Valley Cottage NY US 10989
Job Type : Direct
Reference Code : 20694-MK1
Compensation : 110000.00 - 125000.00 USD/YEAR
Start Date : 08/25/2021
Hours : Full Time
Required Years of Experience : 2
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a Facilities Construction Project Manager for FDA regulated construction projects.

  • Responsible for providing support for the design of the facility, oversight of construction, and qualification of systems & utilities.

  • Define construction materials, operating principles, and testing performance characteristics for utilities and equipment.

  • Ensure that utilities and equipment are built and installed in compliance with the design specifications and all applicable building codes.

  • Ensure that construction meets the principles of reliability, availability, maintainability, and safety.

  • Comply with current Good Manufacturing Practices (cGMPs).

  • Work closely with engineers and architects to develop plans, establish timetables, and determine labor and material costs.

  • Ensure that all drawings and specifications are examined, prior to beginning construction, for design deficiencies, impractical details and possible code violations, by meeting with the Architect and creating resolutions.

  • Manage and direct outside vendors and contractors working on project team.

  • Manage subcontractors and employees, gather permits, and ensure all aspects of the project are up to code.

  • Overall project planning, distributing resources, time management, risk management, creating benchmarks, managing the budget, managing staff, and managing relationships with key stakeholders.

  • Ensure construction project is compliant with current building codes as well as any other legal or regulatory requirements.

  • Maintain regular project reports and journals.

  • Communicate the progress and health of the project with key stakeholders and management.

  • Responsible for PFMEA, FAT, SAT, IQ, OQ, and PQ.

  • Commission new equipment using well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the Production Department that results in a safe and functional environment that meets established design requirements and stakeholder expectations.

  • Manage Risk, identify and respond to potential issues throughout the life cycle of the project minimizing potential negative impacts and helping to ensure safety.

  • Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.

Required Qualifications :

  • BS Engineering or Technical Degree.

  • Minimum 2 years experience with construction project management in Medical Device Manufacturing, Pharmaceutical, or FDA regulated environment.

  • Experience with OSHA regulations, cGMPs and building / construction codes.

  • Experience with Computer Aided Design and CMMS (Computerized Maintenance Management Systems).

  • Experience with HVAC, Air Balancing, HVAC Controls and BMS (building management systems).

  • Experience executing PFMEA, FAT, SAT, IQ, OQ, and PQ.

  • Generate technical documentation for Maintenance Operations such as work instructions for production processes.

  • Train staff Supervise operator training.

  • Requires some foreign travel.

  • Position requires continuously regular standing, walking, bending, and dexterity.

  • Requires ability to continuously practice and follow all safety procedures and PPE requirements.

Contact: Monique Kleiman

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