Less than 5 years experience • Biotech/Pharma
*looking for the Machine and fixture qualification (IQ, OQ , PQ)
Provide leadership, planning and technical support for the introduction of processes for new product development and existing manufacturing.
Key responsibilities/essential functions include:
• Complete qualification and verification activities for new equipment being commissioned for new product lines. Update existing equipment and complete qualifications for NPI integration.
• Draft and release work instructions for new product lines. Update instructions on existing work instructions to incorporate new products as necessary.
• Work through change control processes for design and manufacturing changes
• Ensure regulatory compliance through Qualification & Validation. Responsible for ensuring rigor in determining processes requiring validation, development of plans and analysis criteria, execution and final analysis and acceptance
• Drive continuous simplification of QMS methods and their applications by working with cross-functional team including Operations and Quality Assurance.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements
1. B.S. Degree in Mechanical, Electrical, IndustrialEngineering or related technical degree and 3 years’ experience or Associates Degree and 5 years’ experience or High School diploma with 7 years of experience in production, engineering or troubleshooting
2. Demonstrated troubleshooting, analytical and planning skills
3. Ability to work independently
4. Demonstrated strong communication skills (written and verbal) to all levels of the organization
5. Ability to identify and implement Best Practices