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Full-time
bachelor degree
Posted 12d ago
~40 hrs/week
Responsibilities
The HVAC CQV Lead is responsible for planning, preparing, and leading a field execution team to ensure HVAC commissioning and qualification activities meet project objectives, budget, and schedule. They coordinate cross-functional teams, manage documentation, and ensure compliance with GMP, safety, and environmental standards.
Requirements
Candidates must hold a minimum of a Bachelor's degree in Engineering or Science, with a preference for Chemical, Mechanical, or Pharmaceutical Engineering. A minimum of 10-12 years of experience in Utility and HVAC Commissioning and Qualification within the biopharma or pharmaceutical industry is required.
Full job description
Job Summary
The HVAC CQV Lead is responsible for supporting the planning, preparation and leading a field execution team of C&Q specialists with the CQ activities related to HVAC for meeting the agreed objectives regarding budget, schedule and C&Q methodology according to the Project Commissioning and Qualification Plan, and ensuring URS, GMP, Safety and environmental objectives are met
Main responsibilities
Main responsibilities and tasks of the incumbent includes but are not limited to:
Leading and coordinating a commissioning team that consists of commissioning and qualification leads/specialists, operations personnel, system leads/engineers, document controllers and external vendors and contractors
Planning and scheduling the commissioning activities according to the Project Commissioning and Qualification Plan, project schedule and its associated documents, including:
Meeting and delivering Key Project Milestones
Developing positive working relationship foster collaboration with Quality
Defining workflows and approval cycles for commissioning test plans and specifications
Updating the Project Commissioning and Qualification Plan and its related documents as well as other project specific procedures with commissioning relevance.
Updating the commissioning schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
Guiding the preparations of commission test plans and specifications to ensure unique structures and formats and testing standards
Reviewing commissioning test plans and specifications prior to their approvals
Progress tracking of the preparation of commissioning test plans and specifications
Coordinating the planning and scheduling of commissioning activities with the construction project manager, construction C&Q, and with other disciplines (Construction, Automation, Electrical, Instrumentation, User operation and Site engineering, etc.)
Guiding and controlling of the CQ execution, including:
Ensuring the fulfilment of the general pre-requisites, needed to start with commissioning execution to determine when systems are ready for beneficial use (Construction Completion, availability of tools, utilities, spares, documents, etc.)
Ensuring sufficient safety training for all involved persons
Coordinating the interfaces of the commissioning execution (Construction Management Contractor, Building/ Building Services, Qualification, Automation, Instrumentation, Electrical, etc.)
Performing daily coordination meetings to fine-tune the commissioning execution with all involved parties
Tracking and reporting of commissioning progress
Tracking of deficiencies, including planning and executing the remediation actions
Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging
Reviewing commissioning test reports prior to their approvals
Assisting system leads/engineers with system handover to production
Key Performance Indicators
Ideal Background
Education (minimum/desirable): Minimum BS or equivalent in Engineering or Science - preferably in Chemical, Mechanical or Pharmaceutical Engineering.
Experience in Utility & HVAC Commissioning and Qualification.
Languages: English - fluent in speaking and writing.
Experience: Minimum 10-12 yrs.
Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
Now part of the Efor Group | Committed To Excellence
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Toronto, Ontario
LinkedIn followers
42,053
PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.
At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
Offices: 23 Lesmill Road, Suite 410, Toronto, Ontario M3B 3P6, CA · 2475 Northwinds Parkway, Suite 200, Alpharetta, Georgia 30009, US · 2500 Regency Pkwy, Cary, North Carolina 27518, US · 866 Yuhangtang Road, Hangzhou, CN · 116c 2F Quang Trung Street, Haoni City, VN
How many Engineering jobs are open in Raleigh, NC right now?
There are currently 1,679 open engineering positions in Raleigh, NC listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Raleigh, NC?
Companies currently hiring include Hitachi Energy, Eaton, HDR, JE Dunn Construction, Whitman, Requardt and Associates, LLP, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Raleigh, NC?
Yes — 546 of the 1679 open engineering positions offer remote or hybrid work (111 remote, 435 hybrid).
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