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Technical Operations, Pharmaceutical GMP

Elkton, VA

Posted: 01/25/2023 Job Number: 22942839

Job Description

100% Onsite.

Project Description:
  • Achieve Safety, Quality, and Environmental compliance excellence in all assignments.
  • Prepare, track and report on component, equipment, and raw material supplier issues/ inquiries.
  • Leading and conducting technical investigations and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation.
  • Assessing vendor change notifications for product, process, and regulatory impact.
  • Communicating with vendors to obtain compliance and validation documentation.
  • Work closely with procurement and materials management to ensure material control compliance.
  • Writing, reviewing, improving documentation for technical and regulatory compliance excellence.
  • Contributing to process and equipment safety reviews and performance qualifications.
  • Assess viable alternate source(s) for components by reviewing functionality and safety requirements to ensure that components can be integrated into the process.
  • Assist with training of operations and maintenance personnel as needed on GMP equipment.
  • Current example are the FIT units and general integrity test setup and troubleshooting.
  • Position is very change control focused.

Required Skills:
  • B.S. Or M.S. Degree in biology, biochemistry, biochemical engineering, biological systems engineering, biomedical engineering, chemical engineering, chemistry, integrated science, or mechanical engineering.
  • 2+ years of relevant industrial experience required.
  • Must have some type of change management experience (systems, controls, etc.).
  • Experience in a GMP environment/knowledge of GMP principals.
  • Strong problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field.
  • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
  • The ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.
  • Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications.
  • Willingness to work as a contributing member of a dynamic team of individuals.
  • Single Use Component/Filtration experience.
  • Manufacturing environment experience.
  • Experience working in a cGMP environment.
  • Technical writing skills.
  • Supplier management or supply chain experience.
  • Production/shop floor experience.
  • Experience working w/suppliers (supplier management, supplier interaction).
  • Sterile/aseptic processing experience .
  • Past experience with change management, manufacturing, Quality ops .

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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