Project Controls Manager/Project Planning Manager/Project Engineer (Pharmaceutical Manufacturing) - Expert In Recruitment Solutions

we have an immediate opportunity here for a specific Pharmaceutical Manufacturing Project Engineer. Candidates for this role could have a variety of titles. Please note this is not an IT role; do not send me candidates who are IT PM's. Do not send people who have not spent career in Pharmaceutical industry either.

Please note that this is NOT AN IT position at all. Please do not submit IT Project Managers. Candidates must have extensive Engineering background in Pharmaceutical environment. Not IT or Software Engineering...Validation, Scheduling, Planning, Process Control etc.


Seeking Someone who understands end-to-end manufacturing processes and can partner with various teams to provide guidance in planning out project schedules . A strong background in Life Sciences is required , as this individual will need to understand the manufacturing process as it relates to Life Sciences/Pharmaceutical processes supporting Gene Therapy, as well as understand regulated environment (GxP) and regulatory filing processes.


Industry: Life Sciences/Pharmaceuticals

Project :
Provide back-end project services (Planning, scheduling, and general project management) to support our Gene Therapy Innovation Center (GTIC) project. Back-end project support includes operational readiness activities occurring from OQ completion through licensure – PQ, EMPQ, Water runs, Engineering batches, PPQ, and licensure. Services include (but are not limited to):

• Planning: Work with SMEs to develop and refine existing project back-end schedule activities for various operational readiness sub-teams through meetings, workshops, etc. (P6 experience required).
• Develop visual tracker of schedule milestones (NetPoint preferred).
• Implement best practice tracking tools, KPIs, and dashboards for Operational Readiness schedule.
• Attend sub-team and core team meetings and help drive standardization across workstreams.
• Interface with project delivery (construction/start-up/CQV) team and schedulers as required to integrate Op Readiness activities with overall capital project.
• As required, general PM activities to assist the Operational Readiness Lead including: agenda setting, meeting minutes & action tracking, development of reports & dashboards, etc.
• Create alignment with cross-functional client departments, including Design, Construction, Validation, Manufacturing, Quality, Supply Chain, and Engineering.

Requirements

• Bachelor's Degree in Life Science, Engineering, or related discipline and/or comparable military experience.
• 12+ years of advanced Project Controls Engineering, Project Management, Planning and/or related experience.
• 7-10+ years working in Life-Sciences (Pharmaceutical), regulated environment include experience with:
  • Capital Project Management (including Project Controls and Scheduling)
  • Facility Management & Builds
  • Tech Transfers
  • Validation Life Cycle (including Commissioning and Qualification, Process Validation, Computer System Validation, etc.)
  • GxP Automated Systems
  • Due Diligence & Business Strategy
  • Quality, Regulatory, & Compliance
• Minimum 3-5 years of scheduling and/or project controls experience within life sciences, industrial manufacturing, or other capital-intensive sectors.
• Extensive experience with Primavera P6 for scheduling.
• Experience with Netpoint Planning/Scheduling too preferred.
• Proficiency with MS Project and MS Office, including strong MS Excel capabilities.
• Ability to analyze complex project data and then deliver clear, articulate, and concise messages in a compelling manner to support decision making process.

Project consulting perspective, PM
Experienced planner / project manager who is familiar with life sciences back-end schedule support
Understanding of:

• PQ, PPQ, engineering, batch of water run, regulatory filing

Have a scheduler who can go in and make updates to a schedule. Need someone Mary can work with who knows the logic behind the schedule. Can work with teams and make sure as they are building out their plans that they have the right predecessors in place. (ex: you can't start your water runs until you have your control system qualified.) someone who can help the team step through planning out their schedules and work with the scheduler who doesn't have this in depth life sciences understanding.
Someone else is working on the cost side – this resource will be working on the scheduling support.
Years of experience: 15 in Pharma
Scheduling software: Primavera