Pipeline for CQV Talent - Europe
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Skills
About the role
Job Description
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry.
CQV Engineers/CQV Consultants Locations: Across Europe (Ireland, UK, Netherlands, Belgium, Germany, Switzerland, Spain, France, Italy, Denmark, and more). Contract & Permanent Opportunities Available soon.
We are building a network of experienced CQV professionals across Europe to support current and future projects within the Pharmaceutical, Biotechnology and Medical Device sectors.
As a CQV professional, you will support commissioning, qualification and validation activities for GMP-regulated facilities, equipment, utilities, systems and processes. You will work closely with project, quality, engineering and operations teams during project delivery, start-up and regulatory readiness phases.
Typical Responsibilities
- Develop and execute Commissioning, Qualification and Validation documentation
- Author IQ, OQ and PQ protocols and reports
- Support FATs, SATs and vendor testing activities
- Execute commissioning and qualification activities on-site
- Perform system walkdowns and punch-list management
- Review URS, FRS, DDS and technical specifications
- Support GMP compliance and regulatory requirements
- Investigate deviations and support CAPA activities
- Work across process, clean utility, facility and automation systems
Requirements
- Degree in Engineering, Life Sciences or similar discipline
- Experience within Pharmaceutical, Biotech or Medical Device environments
- Experience with GMP-regulated projects
- Knowledge of IQ/OQ/PQ methodologies
- Experience with utilities, equipment, facilities, automation, or CSV preferred
- Ability to work on-site and travel across Europe when required
Highly Sought-After Experience
- Sterile manufacturing
- API facilities
- Fill Finish projects
- Clean Utilities
- HVAC Qualification
- CSV / CSA Validation
- DeltaV, Siemens PCS7, Rockwell or SCADA Systems
- Annex 1 and FDA-regulated environments
Qualifications & Requirements
- Bachelor of Science in Engineering.
- 2+ years of relevant experience, years of experience will determine level of role suited to you.
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Preferred Qualifications
- Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of
pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
Physical Demands
- Must be able to: stand, sit, and walk for prolonged periods, stoop, kneel, crouch, and crawl as required.
- Must be able to lift and move objects weighing up to 50 pounds and climb ladders as necessary.
Work Environment
- Can work in both indoor and outdoor environments, which may include exposure to varying working conditions.
- Can adhere to strict cleanroom gowning protocols.
Travel
- This position will have up to 100% travel, or as required by the assigned project.
- Position may be assigned to the client site for an extended period of time.
- Overnight travel or staying in the city of the Client’s location is possible, depending on the assignment.
- Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
- Must have access to reliable transportation.
Safety
- This position is a safety-sensitive position.
- The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
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