(Asst) Project Manager, Lab Equipment Validation – Pharma Manufacturing

Our client, a highly successful pharmaceutical consulting firm, is working on the buildout of a multi-billion dollar manufacturing facility.  It is an enormous undertaking that involves the validation of all development and manufacturing equipment. 

This Project Manager (or Assistant Project Manager, client is open on level) will coordinate many of those efforts. We seek an exceedingly sharp, organized and can-do candidate. 

Company will offer generous wage to attract and retain the right person.

Key Things to Note:

• The NC-based facility is large, encompassing 5 buildings with 100s of equipment/units to be validated.  The validation efforts will be extensive and this A/PM will be responsible for 50-60 units.
• Equipment types will include:     
  • Autoclaves (load configuration; SIP Testing)
  • Incubators (walk-in and stand-up)
  • Refrigerators and Freezers, including Blast Freezers
  • Parts Washers (load configuration; cleaning validation)
  • ph Meters
  • Scales

Some familiarity with these tools and equipment types will be important.

• This A/PM will work with client personnel (including CQV team) and other colleagues to plan all validation efforts.  This will include:
  • Determining (and documenting) validation testing strategies and SOPs
  • Developing a timeline for prioritization
  • Ensuring all materials are available when needed
  • Ensuring all stakeholders are aware of their responsibilities and that they are available at prescribed times
• This A/PM will drive this effort. They will:
  • document and communicate validation project plans
  • oversee execution
  • ensure timelines are understood and materials are in place
  • monitor compliance
  • troubleshoot issues
  • document progress
  • develop (and communicate) revised project plans
  • ensure that all parties are working in unison to achieve desired outcomes

We seek a skilled and savvy project manager.  Someone with proactive and thoughtful planning skills, diligent and astute monitoring skills, excellent documentation skills, keen problem-solving skills and the ability to communicate clearly, succinctly, persuasively and on a timely basis.

• The company uses Excel and MS Project to track and manage project activity.  Seek technically-savvy candidate with Advanced Excel and substantial exposure to other project mgmt tools.
• This position will be on-site in Holly Springs, NC.  While there is occasional opportunity to work remotely, client seeks candidates who like to be on-site where the action is.

Targeted candidate will offer a BA/BS degree and 1+ years working with equipment types noted above.  Some familiarity with CQV processes would be valuable.

In addition we seek candidate with the demonstrated ability to manage projects by coordinating the resources, timelines and people needed to achieve a shared goal.  Advanced Excel expected and required.  Exceptional work ethic, job ownership and mission-driven work style, equally important.

This is an immediate need and a Direct Hire opportunity.  Tremendous growth potential for top candidates.  Please forward Word resume for prompt consideration. 

Local candidates targeted.