This is a global role providing strategic process/equipment engineering guidance on projects and ongoing operations for key Pfizer Global Supply Biotech and Sterile Injectables sites (and external partners). The primary purpose of this role is to provide technical leadership and develop innovative solutions for various aseptic technologies across the Pfizer network and relevant Contract Manufacturing Organizations (CMOs).
- Responsible for providing process engineering support to manufacturing sites to resolve technical issues, support capital projects and promote knowledge sharing and technology replication.
- Is a recognized Subject Matter Expert, across various aseptic technologies and has knowledge of standards and concepts in other engineering disciplines
- Maintains knowledge of contemporary aseptic technologies, equipment innovations and regulatory standards
- Interprets internal/external business, regulatory/ compliance issues and best practices that impact Pfizer Global Supply
- Exercises own judgment leveraging knowledge and experience. Works independently with instruction on complex problems
- Operates objectively in ambiguous situations using knowledge and work experience to achieve desired results
- Communicates proactively with stakeholders regarding activities, progress, issue and resolution plans relation to equipment and technical initiatives
- An active member of the Biotech and Sterile Injectable Global Engineering Customer Facing Team accountable for strengthening and supporting the wider Global Engineering Team and leveraging wider network experience to support the Operating Unit
- Bachelor’s Degree in engineering or equivalent scientific discipline
- Minimum 10 years in aseptic pharmaceutical manufacturing or in support of that industry
- Strong knowledge of aseptic/sterile drug product processes and equipment and its application in the Sterile Injectables and Biotechnologies operations.
- Familiarity with relevant quality and regulatory requirements and trends and cGMP’s (e.g., FDA, EU Annex 1, PIC/S, PDA, ISPE, Pfizer PQS, etc.).
- In depth knowledge of one or more of the following areas:
- Fill/Finish equipment & aseptic processing technologies
- Automated Visual Inspection stopper processors,
- Isolator technologies and Restricted-access barrier systems (RABS)
- Sterilization methods
- Manufacture and automated assembly of SI devices and assemblies
- Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations and technical leaders.
- Ability to support technical programs and initiatives, fostering support from stakeholders and collaboration among participants.
- Proven ability to work in a cross-cultural environment and provide technical management while working remotely.
- Appropriate business acumen to provide guidance on equipment and capital investment strategies.
- MS or equivalent
- 10+ years in pharmaceutical manufacturing, preferably aseptic processing and/or engineering.
- Sitting, Standing, Walking, Driving associate with travel, Data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Up to 40% overnight travel including international locations
- Collaborate with other Global Engineering groups and leaders, and other technical groups in Global Technology and Engineering Microbiology and Aseptic Support (MAS) PGS sites and Worldwide Research & Development (WRD) on innovative technical solutions and platform technologies
- Vendor Relationships / Management - Strengthen partnerships with key vendors to facilitate issue resolution, after sales support, etc.
- Communicate proactively with stakeholders, senior leaders and sites regarding activities, progress, issues and resolution plans related to supported activities.
- External industry groups (ISPE, PDA, etc.)
- Manages contractors, vendors and contingent workers as needed
ADDITIONAL POSITION DETAILS
- Last date to apply: Nov 4, 2022
- Work Location Assignment:Flexible; Ideally in Midwest US (relative to Kalamazoo, MI and Lake Forest, IL) or Mid Atlantic US (relative to Rocky Mount and Sanford, NC) US, and close to a major airport
Relocation assistance may be available based on business needs and/or eligibility.
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.