- 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 install 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 install, 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, 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 as 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
- 8+ 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.
- Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is required.
- Experience with commissioning & qualification of process control systems are considered an asset.
- Lead teams of staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
- Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
- 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
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Clean Utilities Engineer PQ LEAD - North Carolina, United States - MMR Consulting
Description
Previous Pharmaceutical/Biotech experience is MANDATORY for this role.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in the US and Canada. Its services include Engineering, Project Management, and other Consulting services. MMR's Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).
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, which are typically in the RTP, NC area.
Responsibilities
Qualifications
Send your resume to:
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
