CQV Junior Consultant - Pharma Manufacturing Equipment
: Job Details :

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 Consultant will be assigned as the Project Manager of many of those efforts, including the FAT (Factory Acceptance Testing) for purification equipment, an enormous undertaking for this buildout. We seek an exceedingly sharp and can-do candidate who combines knowledge of CQV of pharma equipment with superb organizational and project management skills.

This is an outstanding opportunity for an overachieving up-and-comer who seeks a career in pharma manufacturing and/or consulting.

Key Things to Note:

The NC-based facility is large, encompassing 5 buildings with hundreds of equipment/units to be validated.

• The initial focus of this role will be coordinating all FAT efforts, specifically for purification/filtration equipment, but the role will expand beyond that.
• Other equipment types will include Autoclaves, Incubators, Refrigerators and Freezers, Parts Washers (load configuration; cleaning validation), pH Meters, Scales, etc.
• Some familiarity with these tools and equipment types will be important.

This Consultant 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 Consultant will drive this effort.

• They will document and communicate 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, and 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.

This position will be on-site in Holly Springs, NC.

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

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

This is an immediate need and a Direct Hire opportunity. Tremendous growth potential for top candidates.

Please forward resume for prompt consideration. Local candidates targeted.