Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical role in developing and modifying process formulations, methods and controls to meet quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production. As manager you are responsible for technical leadership of device and combination product lifecycle management at Rocky Mount manufacturing site.  This is Site-facing role to establish technical Medical Device and Combination Product (MDCP) programs and sustain on-market MDCP products through change and risk management. You will be able to take a cross functional leadership role to facilitate agreements between different team.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Maintain compliance of on-market device/combination product with Design History file (DHF) and technical files

• Establish and support change management, risk management and Quality System deliverables for MDCP products

• Coordinate technical support for MDCP remediation initiatives (plan and execute studies; write technical reports summarizing results; generating / organizing necessary data to support product impact assessments, etc.)

• Facilitate, support, and/or execute verification of device components/system, including risk assessments, risk mitigation strategies and risk plans

• Develop technical impact assessments for change requests related to device/combo product design; develop execution plan and support manufacturing, engineering and validation to implement those changes

• Support investigations of delivery system customer complaints or manufacturing related investigations to determine root cause and implement appropriate corrective and preventive actions

• Partner with site technical support team for discrepancy and investigation resolution, equipment and process validation activities, test method validation, training on new device related process technologies and on significant changes to related manufacturing procedures

• Identify and lead process/product/device improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance

• Participate in start-up efforts of new equipment, software or processes or commercialization of new device/combo products, serving as a technical device SME for process-related issues at the facility

• Collaborates with other technical support groups to implement process technology initiatives, including scoping new capital investments

• Support establishment of trending/monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process variance

• Ensure preparedness to represent the DHF / technical files during regulatory and 3rd party inspections

• Partner with manufacturing to meet the production schedules, ensure commercial supply, uphold quality standards, driving towards zero defects.

Qualifications

Must-Have

• Must have a High School Diploma (or Equivalent) and 10 years of relevant experience in medical devices & combination products

• OR an Associates Degree with 8 years of experience in medical devices & combination products

• OR a Bachelors with at least 5 years of experience in medical devices & combination products

• OR Masters Degree with more than 3 years of experience in medical devices & combination products

• OR a PhD with 0+ years of experience medical devices & combination products

• Familiar with global regulations on devices and combination products, drugs, and validation/qualification requirements

• Excellent communication skills (written and verbal) and attention to details

• Demonstrated problem solving and team leadership abilities

Nice-to-Have

• Relevant pharmaceutical experience

• 5+ or more years’ experience in a manufacturing facility for device/combo products (pre-filled syringes) preferred

• Experience working with and knowledge of 21 CFR Part 4 Subpart B, 21 CFR 211.198, 21 CFR 820.198, and 21 CFR Part 803

• Experience in the area of quality assurance, quality control of medicinal products with good knowledge of warehousing activities

• Good knowledge of pharmaceutical legislation and experience in relevant guidelines, operations and/or quality

Non-Standard Work Schedule, Travel, or Environment Requirements

• Able to travel 20% or more.

Last date to apply: 4/11/2023

Relocation assistance may be available based on business needs and/or eligibility.