Technical Operations Contractor - 21-03159

Position: Technical Operations Contractor - 21-03159
Location: Elkton, VA
Duration: 12 Months

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.
  
  

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:

• 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:

• Manufacturing environment experience
• Experience working in a cGMP environment
• Technical writing skills
• Production/shop floor experience
• Experience working w/suppliers (supplier management, supplier interaction).
• Sterile/aseptic processing experience.
• Experience working with change management/change controls