Pharma Equipment Validation, Project Lead - Pharma Consulting Firm

Our client, a highly successful RTP area firm that provides consulting services to pharmaceutical companies worldwide, is actively recruiting a top-notch candidate to join its client services team. 

These are project management roles. The firm is engaged by its clients to lead high-impact, high-cost initiatives such as major buildouts, capital improvements, operations excellence programs, etc. Consultants are embedded into the client’s organization and drive the execution of these projects.

These are challenging roles. Consultants take over the day-to-day management of the projects, and we seek candidates who are take-charge, get-things-done leaders but also hands-on, adaptable, and resourceful team players.

Key Things to Note:

• For their initial engagement this Consultant will work with an RTP, NC area clientthat is building out a $2 billion pharma biomanufacturing facility. This is a cell culture CDMO.
  • As part of the process, all equipment must be validated. 
    • There are 100s of pieces of equipment across multiple buildings. 
    • It is an enormous challenge that must be meticulously planned out and managed. 
  • The firm will work in partnership with client leadership to plan the timetable, scope, testing/validation strategies, resources, materials, assigned parties, etc.
  • Consultant will drive the project based on the action plan.
• This Consultant will begin by managing the validation efforts for all Downstream equipment including:
  • Chromatography Columns – Packing, running, and cleaning a column
  • Centrifuges
  • Buffer preparation and tanks
  • Virus filtration and others

Seek candidate who has worked with downstream processingequipment. Engineering background would be a plus. Familiarity with CQV strategies would also be valuable.

• This Consultant will bring technical know-how to the project as well as be responsible for keeping the initiative on-track.
  • This will involve providing direction to all stakeholders, monitoring progress, troubleshooting issues, and maintaining and communicating records of progress.
  • This will also involve ensuring that all materials and participants are available as needed, based on the timetables set, and adjusted for any revisions.

We seek candidates whose technical bkgd is complemented by the ability to manage complex and dynamic projects.

• The firm uses Excel and MS Project to track and report on many aspects of activity. Advanced Excel skill is required. MS Project would be a plus.
• This is a highly collaborative role. This PM will regularly interface with a wide range of internal and external stakeholders to ensure all aspects of the project are properly understood and executed.  We seek a superb communicator.
• This position is located in Holly Springs, NC. 

Targeted candidate will offer a BA/BS degree in a technical field and 2+ years working with the equipment types noted above. Some familiarity with CQV processes will be important.

In addition, we seek a candidate with the demonstrated ability to manage projects by coordinating the resources, timelines, and people needed to achieve a shared goal.

Finally, Consultants represent the firm. They are the face, eyes, and ears of the firm on a daily basis. We seek super smart, industrious, and professional candidates who have an enormous desire to learn, achieve, and have impact.

This is a Direct Hire opportunity and an immediate need. 

Please forward resume for prompt consideration. Local candidates targeted.