Pipeline for CQV Talent - Europe

Job Description

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

Data Centre Commissioning Engineers / Commissioning Managers

LinkedIn Pipeline Job Description

Data Centre Commissioning Engineers & Commissioning Managers Locations: Across Europe (Germany, Ireland, Netherlands, Sweden, Denmark, Spain, Italy, Switzerland and more) Contract & Permanent Opportunities Available

We are actively building our network of Commissioning professionals supporting hyperscale, colocation and mission-critical Data Centre projects across Europe.

This is an excellent opportunity for experienced Commissioning Engineers, Cx Managers, Lead Cx Engineers and Commissioning Agents looking to support some of Europe's most exciting data centre developments.

Typical Responsibilities

• Lead and support commissioning activities across mission-critical systems
• Execute and review commissioning procedures and test scripts
• Coordinate FATs, SATs and Integrated Systems Testing (IST)
• Verify installation and functionality of electrical and mechanical systems
• Manage commissioning schedules and stakeholders
• Review technical documentation and design packages
• Support handover activities and final client acceptance
• Work closely with contractors, vendors and end clients

Requirements

• Degree or trade qualification in Engineering
• Experience commissioning data centre infrastructure
• Strong understanding of electrical and/or mechanical systems
• Experience with FAT, SAT and IST activities
• Familiarity with commissioning methodologies and documentation
• Ability to work on site and travel across Europe

Highly Sought-After Experience

• Hyperscale Data Centres
• Colocation Facilities
• MV/LV Electrical Systems
• UPS Systems
• Generators
• BMS / EPMS
• Chilled Water Systems
• CRAH/CRAC Units
• Integrated Systems Testing (IST)
• CxA or Commissioning Management experience

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.