Senior Specialist, Engineering - Device & Combination Product - Packaging Technology
3 days ago
Description
• Key member of External Manufacturing & Network Equipment team responsible for leading product/technology transfers to Contract Manufacturing Organizations (CMO). • Serve as key technical interface liaison with internal packaging sites. • Lead project teams and technical staff to solve complex packaging problems. • Establish calibrated technical oversight approach based on product type and capabilities of external partners. • Assurance of compliant packaging process execution and project management. • Function independently, providing coordination, communication, and oversight on technical matters. • Significant experience with packaging operations support and development. • Support technical due diligence assessments and assure technical site readiness for new product introductions. • Lead complex changes of packaging images and materials. • Qualification of changes to distribution and thermal transport/storage systems for finished drug products. • Qualification of functional aspects of container closure systems.
Requirements
• 7+ years of experience working in medical device, pharmaceutical or biotech organizations with hands-on experience with packaging operations support, packaging materials/components, and packaging processes. • Knowledgeable of design control, medical device, combination products, pharmaceutical packaging and related scientific/technical concepts and techniques. • Prior experience working inside a pharmaceutical packaging facility or in an External Manufacturing technical role is desirable. • Highly proficient in project management skills, from conception and initiation through close-out. • Mastery of packaging scientific/technical concepts and techniques, applied to resolve packaging issues. • Significant experience with medical device or combination product transfer, operations support, and materials/components. • Experience using quantitative decision tools for Risk Management and options analysis. • Excellent oral and written communication skills. • Proven ability to provide technical leadership and apply technical skills in a fast-paced, complex environment. • In-depth understanding and proven expertise in application of GMPs, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification. • Strong analytical and decision-making skills.
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