Pfizer Manufacturing System Owner in Durham, North Carolina
The Manufacturing Systems Owner for Biotherapeutics Pharmaceutical Sciences (BTxPS) will lead the BTxPS effort to deliver effective, efficient, and scalable technology solutions for the development of biological therapeutics in partnership with the Digital Strategy and Operations team. This position will be responsible for the compliant oversight and management of our manufacturing applications and manufacturing workflows that improve the flow of data within BTxPS from acquisition through creation of digital products. This position will collaborate with the larger Medicinal Sciences organization, Pfizer Global Supply, Pfizer Digital, and external partners as necessary and drive a technical strategy to deliver solutions that align across the organization.
• Apply systems, compliance, and business knowledge to deliver business goals for manufacturing applications in alignment with BTxPS Digital Strategy.
• Represent BTxPS as lead SME on digital projects with the goal of achieving efficient and consistent data workflows and compliance expectations.
• Lead the deployment and adoption of manufacturing applications, including cloud-based Platforms (PaaS) and Software (SaaS), with consideration for GMP workflows.
• Monitor application metrics to support business operations and measure implementation.
• Ensure that system technology components are appropriately documented and supported.
• Author and review operating procedures for manufacturing applications. • Review application development & validation efforts to confirm adherence to BTxPS business and compliance requirements.
• Partner with Pfizer Digital to execute and review software development lifecycle (SDLC) deliverables.
• Lead investigation of manufacturing application Quality issues.
• Partner with Pfizer Digital and BTx Manufacturing Systems Technical Lead to progress issue resolution, system enhancements and application upgrades
• Train BTxPS colleagues on existing platforms to ensure technology investments are maximized
• Bachelor's degree in Computer science, engineering or related degree with direct experience implementing successful IT solutions in the life science industry.
• 5+ years of experience designing and maintaining manufacturing informatics and business operations environments.
• Understanding of the various systems and platforms required to enable development of biological therapeutics.
• Experience integrating multiple internal & external applications for efficient end to end creation of key deliverables.
• Experience in GMP & non-GMP labs including delivery of cloud-based solutions in regulated environments.
• Familiar with regulatory data integrity requirements
• Ability to work closely with Pfizer Digital & External Partners as required.
• Strong interpersonal communication skills and a track record of delivering solutions for multiple stakeholders.
• Experience supporting solutions in complex environments.
• Experience supporting applications for automation and manufacturing systems.
• Experience partnering with biotech manufacturing for tech transfer and technical alignment.
• Knowledge of key platforms including MasterControl Electronic Batch Records and/or other MES solutions, OSI Pi, DeltaV, IoT, Network Engineering.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• Occasional work outside business hours to accommodate other Pfizer sites, partners and manufacturing schedules.
• Up to 20% travel to Pharm Sci BTx (Andover, MA; St Louis, MO; Durham, NC; Cambridge, UK)
Additional Job Information
Eligible for employee referral bonus
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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