Job Description
TITLE: TECHNICAL OPERATIONS CONTRACTOR - II (ASSOCIATE) GMP/MANUFACTURING LOCATION: VA; ELKTON DURATION: 12MONTHS CONTRACT JOB 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. QUALS-- 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 experience • Manufacturing environment experience • Experience working in a cGMP environment • Technical writing skills
Company Description
We place top talent through our divisions: Technology, Staffing, Professionals, Talent Digitalization, and Pyramid Academy. Our flexible staffing options include contract, contract-to-hire, direct hire, and SOW/Statement of Work. We deliver top talent to our clients by combining the use of the latest technology with the subject-matter expertise that our seasoned team of recruiters brings to the process. With the integration of smart sourcing tools, machine learning, and AI/Artificial Intelligence into our screening process across the organization; we evaluate a large volume of candidates to find the most suitable talent.