Senior CQV Lead

Senior CQV Lead-(LS-0004C8)

Your Impact:

Senior Commissioning, Qualification and Validation (CQV) Lead

At Jacobs, we'll inspire and empower you to deliver your best work so you can evolve, grow and succeed – today and into tomorrow.With more than 55,000 people in 40+ countries, working at Jacobs offers an exciting range of opportunities to develop your career within a supportive and diverse team who always strive to do the right thing for our people, clients and communities.

People are Jacobs’ greatest asset, and the heart and core of our company. We offer a competitive package to attract and retain the best talent.Work-life balance and flexibility is a key consideration at Jacobs. We’re happy to discuss hybrid, part-time and flexible working hours, patterns and locations to suit you and our business.

In order to support our growth strategy we are seeking applications for the position of Senior CQV Lead. As a Senior CQV Lead with Jacobs you will direct project teams to execute and deliver large scale EPCMV Biotech/Pharma projects located in mainland Europe.

Project is located in the greater Copenhagen area, where the purpose is to build, a state-of-the-art facility. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical trials & Commercial Launch. 

Responsibilities include:
• Provide Quality management and oversight of the design and qualification activities
• Develop and maintain the project quality activity plan
• Drive the quality activities during the project execution phase from requirement setting, design through construction, verification and system release for process validation
• Supporting the science and risk-based qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
• Support the execution and reporting of the commissioning, qualification and validation activities 
• Prepare or review all documentation where required specific to quality activities.
• Ensure any deviations are thoroughly investigated and closed in a timely manner
• Train project members in science and risk-based approach to validation 

Here's What You'll Need:

• Significant experience from a similar position within project execution the pharmaceutical or life-sciences industry
• Strong experience with Commissioning, Qualification and Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility
• Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
• Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15
• Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products
• Track record of utilizing Risk Based Approaches to Qualification / Validation activities
• Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements

#LSeurope

Primary Location

:Denmark-Denmark Countrywide-Albertslund-DK - Copenhagen - Albertslund

Travel

:Yes, 10 % of the Time

Job Posting

:Mar 4, 2024, 4:51:45 AM

Job

:Quality

Organization

:PPS

Job Type

:ExperiencedJob Classification:Fulltime-Regular

Work Locations

:DK - Copenhagen - AlbertslundHersted�stervej 27-29, Building AAlbertslund2620Capabilities:Biopharma