Job Description

Description

Here at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We don't settle until we give our best and know that we're making a difference.

As a Commissioning, Qualification, and Validation (CQV) Project Manager, you'll join our collaborative team providing CQV project management to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. This position is client facing with an emphasis on ensuring CQV project deliverables meet schedule, cost, scope, quality, and safety. We are looking for a passionate CQV Project Manager who is driven by collaboration, exceeding expectations, and challenging the status quo.

You'll be accountable for developing CQV planning documents to manage CQV projects, leading the team in generating and executing CQV protocols using Good Documentation Practices (GDPs), leading the team in investigating and resolving protocols exceptions or discrepancies, leading the team developing technical reports and CQV summary reports, and leading the team in startup of equipment in a safe and effective manner; as well as performing risk assessments and impact assessments. You'll also be accountable for establishing appropriate procedures regarding handover of systems from construction to C&Q team as well as handover of systems from C&Q team to client. You will establish appropriate metrics for measuring key project criteria and ensuring that project deliverables satisfy project requirements.

Bring your curiosity, talent for multi-tasking and collaboration, and extreme organizational skills and we'll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together.

At Jacobs, we're partnering across the globe to create the best project outcomes by maximizing the design, digital technology, and support capabilities of our Global Integrated Delivery (GID) teammates. By joining Jacobs, you'll commit to supporting and engaging with these teams, as we work to build a company like no other.

QUALIFICATIONS
Bachelor's degree in Mechanical, Chemical, or Electrical Engineering or equivalent
At least 10 years of CQV experience in the Life Sciences industry
Strong working knowledge of commissioning, qualification, and validation deliverables, team building and client relationship building.
Leadership experience, as well as experience tracking progress according to schedules and cost estimates and experience with training and mentoring junior staff members
Flexibility and willingness to travel and work at various clients' locations

Ideally, you'll also have:

Proposal development experience
Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industry guidance:
o ISPE Baseline Guide 5 Commissioning and Qualification
o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
Six Sigma Certification

LifeSciences, Bio/Pharma, EPCMV