Key Skills
Job Description
Responsibilities
- Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ), Verification for Continuous process, filter dryers, nano-filtration (UFDF), downstream purification, header tanks, feed tanks, Delta V, Utility tie-ins, Purified water & N2 systems.
- Coordination of vendor packages to achieve streamlined CQV.
- Coordination/review of construction packages again to achieve streamlined CQV.
- Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV practices with a focus on black utilities.
- Experienced managing teams.
Qualifications
- Minimum of 10+ years’ experience gained within a Life Sciences environment.
- Relevant experience working on process equipment, Black utilities.
- Experience of working in a project environment.
- Hands on attitude.
- Experienced in managing teams within the Life Sciences.
- Excellent oral and written communication skills in English and German would be an advantage.
- High level of customer orientation/understanding.
- All applications will be treated in strictest confidence.
Core Responsibilities
The Senior CQV Engineer will manage the field execution of commissioning, qualification, and verification for black utilities and process equipment. They will also coordinate vendor and construction packages to ensure streamlined project delivery.
Requirements
Candidates must have at least 10 years of experience within a Life Sciences environment, specifically working with process equipment and black utilities. Strong knowledge of regulatory standards such as ICH, FDA, and ISPE is required, along with proven team management capabilities.
About PM Group
Industry: Business Consulting and Services
Company size: 1,001-5,000 employees
At PM Group, our vision is to enable a world where science and technology transform lives. Powered by exceptional people, digital technology and innovation, we deliver next generation facilities clients count on and society depends on. Employee owned, we work across Europe, the UK, Asia and the USA. Our team of 4,000+ people specialise in the design, construction and commissioning of high-tech facilities. Over 50+ years, we’ve built our expertise working for the world's leading pharma, data centres, food and medical technology companies. We also have an excellent track record in the advanced manufacturing and energy sectors. To excel at the complex work we do, we always seek to understand our clients' needs. At every level of our business you will see a culture of honesty, openness and flexibility. Learn more about PM Group : www.pmgroup-global.com In 2023, we were delighted to welcome Milestone to PM Group. Milestone is a dynamic automation and digital systems consultancy. The Company provides world-leading services to the Life Sciences and FMCG sectors. With 160+ experts, Milestone has extensive experience covering lean analysis, process optimisation, system integration, equipment automation, MES solutions, manufacturing intelligence and project management. To find out more about Milestone, visit : www.mile.ie (disclaimer and legal information can be found at: www.pmgroup-global.com)