Job Description

QUALIFICATIONS:

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 * Supplier management or supply chain experience. • Production/shop floor experience. • Experience working w/suppliers (supplier management, supplier interaction). • Sterile/aseptic processing experience

RESPONSIBILITIES:

• 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.

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

Company Description

AA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value. AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.