Previous Pharmaceutical/Biotech experience is mandatory for this role.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work may require working out of client's facilities, in Raleigh North Carolina.
Responsibilities
- Provide technical guidance into the design, installation commissioning, qualification, start-up and operations of various pharmaceutical / biopharmaceutical facilities and utilities such as Purified Water (PW), Water For Injection (WFI), Clean Steam (CS), Heating, Ventilation & Air Conditioning (HVAC), Process Compressed Air (CA) & Gases
- Lead the development of key design, technology selections, engineering and commissioning / qualification deliverables such as PFDs, P&IDs, specifications, equipment and distribution loop layouts, DQ, FAT, Commissioning Test Plans & checklists, IQ, OQ, PQ during the project lifecycle
- Able to support detailed design development, field installation and perform field execution of commission & qualification test cases and protocols
- Serve as technical SME on the design and operation aspects of clean utilities. Possess knowledge of regulatory requirements, mechanical specifications and industry best practices and guidelines for clean utilities.
- Lead the design, procurement, field installation, commissioning and qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
- Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
- Coordinate meetings with cross-functional departments, to drive design reviews, project progress, facilitate decisions, and provide updates.
- Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
- Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases.
- Visit construction and installation sites, wearing necessary safety PPE.
- You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
- Supervise contractors during critical testing of system and equipment.
- Other duties assigned by client, and/or MMR, based on workload and project requirements.
- As this position requires working on client sites, you will need to comply with the client's safety rules including mandatory vaccination policies for COVID-19, where applicable
Qualifications
- 5+ years of experience in commissioning, qualification or validation of various clean utility systems within the pharmaceutical/biotech industry.
- Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
- Expertise in generation, storage and distribution of pharmaceutical-grade water systems
- Hands-on experience with industrial utilities, including:
- Compressed air generation and distribution
- Ammonia chillers
- Electro boilers
- Chilled water generation and distribution
- Cooling water generation and distribution
- Chilled glycol generation and distribution
- Cooling towers
- Hands-on experience with clean utilities, including:
- Purified Water (PW) generation
- Water For Injection (WFI) generation
- Clean Steam (CS) generation
- Hands-on experience with HVAC systems, including:
- Air handling units (AHUs)
- Dedicated outdoor air systems (DOAS)
- Blower coil units
- Air curtains
- Computer room air conditioning (CRAC) units
- DX cooling units
- Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
- Experience with commissioning and qualifications of process control systems are considered an asset.
- Lead teams of staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset but not required.
- Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexities.
- Possess mentorship skills, to coach and develop junior and intermediate employees.
- Engineering degree, preferably in Mechanical, Electrical or Chemical.
- Travel may be required on occasion.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills
