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