Remediation Project Manager

Highly Competitive Salary
  1. Contract
  2. Good Manufacturing Practice (GMP)
  3. United States
Marion, USA
Posting date: 05 Dec 2019
QA.MK.26829_1575581754

Proclinical is currently seeking a Project Manager for FDA Remediation Projects for a pharmaceutical company located in Marion, NC. Successful candidate will function as the owner representative on major capital projects associated with remediation while providing consulting, engineering and facilities project management services.

Job Responsibilities:

  • Independently plan, execute and direct cross functional engineering projects, that may cross traditional product lines. Seek diverse new approaches to problems encountered through adaptation and modification of standard engineering principles.
  • Manage projects on a cross functional basis, including direct supervision of team members.
  • Manage the project costs (all financial aspects) of product development. This will include capital expenditures and cross functional expenses.
  • Identify and resolve complex problems, including the development of new design of experiments, without supervision.
  • The following projects and associated work have been identified but can be adjusted based on client needs.
  • Water for Injection (WFI) system
  • Solution Transmission System (STS)
  • CIP Systems associated with STS
  • North and South Mix Construction (coordination with WFI/STS)
  • Participate in operational meetings with Leadership Team for project performance and financial metrics.
  • Preparation of FDA and Senior Leadership communications and presentations.
  • Additional engineering consulting/support service requested by the client.

Skills and Requirements:

  • Minimum of a completed Bachelor of Science in Engineering or Science discipline
  • At least 8-10 years relevant experience; plus, an additional 2-5 years of matrix management experience
  • Certified Project Management Professional (PMI or IPMA or equivalent certification) required
  • Competent application of Baxter's Vital Behaviors and Leadership Essentials\
  • Understanding of Good Manufacturing Practices
  • Demonstrated competencies in all aspects of project management
  • Ability to develop others
  • Good communication skills with matrix management experience required
  • Independent judgment in the evaluation, selection and adaptation of various engineering techniques required
  • Microsoft Word, Excel, Outlook, PowerPoint, and Project preferred
  • Previous regulated industry experience strongly preferred
  • Previously experience working on an FDA Remediation project(s), preferred

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Max Kelly at (+1) 312-270-1613 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#Compliance/Quality

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