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Senior Commissioning, Qualification and Validation (CQV) Lead

At Jacobs, you will work with the most talented professionals and thought leaders to shape the future of the global professional services sector as we deliver ground-breaking and life-changing solutions for a more connected, sustainable world. With more than $12 billion in revenue and a talent force of more than 50,000, Jacobs provides a full spectrum of services including scientific, technical, professional construction and program-management for business, industrial, commercial, government and infrastructure sectors.

In order to support our growth strategy we are seeking applications for the position of Senior CQV Lead. As a Senior CQV 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.

Here’s What You’ll Need:

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

Experience required:

• 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.

Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. Learn more about your rights under Federal EEO laws and supplemental language.