Technical Operations, Pharmaceutical GMP

TECHNICAL OPERATIONS, PHARMACEUTICAL GMP ELKTON, VA 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.

• 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 .