Sr. CQV Start-Up​/Commissioning Project Manager; LSNA

Position: Sr. CQV Start-Up/Commissioning Project Manager (LSNA)
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 Sr. Commissioning, Qualification, and Validation (CQV) Start-Up/Commissioning 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.  You will also be responsible for the development of start-up and commissioning plans, commissioning documentation and hands-on execution of these plans for a variety of facilities, systems and equipment.

We are looking for a passionate Sr. CQV Start-Up/Commissioning 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. You will lead a team who will oversee, coordinate and execute the start-up and commissioning and visual inspection of both clean and dirty process utilities.

Utility systems to include: water softeners, water filtration, chilled water/cooling towers, HVAC, cooling distribution units, and related equipment.  You will also develop Start-Up and Commissioning Plans for utility systems (generation and distribution). This individual will apply engineering knowledge of, and experience with, HVAC, utilities, electrical and electrical backup systems, instrumentation, controls, and automation to support clients. The CQV Start-Up/Commissioning Project Manager will also develop client relationships and act as Jacobs point of contact on project/client sites.  

You will seek new project opportunities for Jacobs.

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. 

-    Bachelor's degree in Mechanical, Chemical, or Electrical Engineering or equivalent years of experience in lieu of degree

-    At least 10 years of CQV experience in the Life Sciences industry

-    At least 8 years of Start-Up and Commissioning experience

-    Strong working knowledge of start-up and commissioning with extensive experience in building teams and maintaining client relationship.

-    Expert level working knowledge of qualification and validation deliverables.

-    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:

- Experience with a digital platform such as EIDA or KNEAT

-    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  …