Technical Operations Contractor - II

Job TitleQualifications:Education Requirement: 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.Required Skills: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.A willingness to work as a contributing member of a dynamic team of individuals.Heavily Preferred:Single Use Component/Filtration experienceManufacturing environment experienceExperience working in a cGMP environmentTechnical writing skillsSupplier management or supply chain experience.Production/shop floor experience.Experience working w/suppliers (supplier management, supplier interaction).Sterile/aseptic processing experienceResponsibilities:Achieve Safety, Quality, and Environmental compliance excellence in all assignmentsPrepare, 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 implementationAssessing vendor change notifications for product, process and regulatory impactCommunicating with vendors to obtain compliance and validation documentationWork closely with procurement and materials management to ensure material control complianceWriting, reviewing, improving documentation for technical and regulatory compliance excellenceContributing to process and equipment safety reviews and performance qualificationsAssess 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.Comments/Special Instructions: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.Position is very change control focused.Past experience with change management, manufacturing, Quality ops