ROLE SUMMARY
This is a global role as a subject matter expert providing process/equipment guidance in the design and operation of Visual Inspection equipment for Pfizer Global Supply sites and external partners. The primary purpose of this role is to provide strong technical leadership and support the deployment of innovative solutions in support of the Global Sterile Injectables and Biotechnologies Operating Units.
This role will report to the Visual Inspection Lead, supporting strategic initiatives and understanding business objectives related to the visual inspection process.
This role will also support strategic direction related to automated visual inspection and related technologies. It will be necessary to partner with equipment and technology vendors to develop solutions for parenteral operations.
ROLE RESPONSIBILITIES
The primary function of this role is to facilitate the implementation and use of visual inspection systems by:
- Serve as a key business technical representative for visual inspection process-related issues that can have significant business impact
- Lead business effort for new visual inspection systems
- Implement portfolio-wide product changes to support global process initiatives
- Interface directly with Network partners on process changes that impact multiple sites to define the best solution for Pfizer
- Serve as process technical representative for Network support
- Lead AVI projects to support network sites.
- Is a recognized Subject Matter Expert in Visual Inspection and Container Closure Integrity Testing technologies and quality/compliance requirements.
- Provides technical guidance and support for the design, implementation, qualification, validation and operation of Visual Inspection technologies
- Works with leadership to develop support development of automated visual inspection strategy and direction.
- Provide troubleshooting, root cause analysis serving as scientific and technical subject matter expert on issues that affect Visual Inspection and Container Closure Integrity
- Support strategic visual inspection projects and programs to optimize network resources and costs.
- Manage Implementation of Visual Inspection Technical Transfer to CMOs
- Supports FDA and other regulatory inspections as subject matter expert in AVI technology and related projects.
- Maintains knowledge of contemporary requirements, industry standards and regulatory standards
- Mentor colleagues to develop their capabilities and ensure Visual Inspection program sustainability and continued alignment with Network Standards
- Works independently on most assignments using knowledge and work experience to achieve desired results
BASIC QUALIFICATIONS
- BS or MS in Engineering, business, or Science required
- 8 years related experience in the development or support of processes, quality systems or a closely related field
- Excellent communication skills and attention to details.
- Demonstrated ability to lead strategic projects with large multi-discipline teams by developing strategy and leading team through project completion.
ADDITIONAL SKILLS/PREFERENCES:
- Demonstrated ability to perform as a process leader when interfacing with all areas of Pfizer’s network
- Strong understanding of Visual Inspection and Container Closure Integrity Testing Regulatory requirements
- Strong qualification and validation skills and experience
- In-depth experience in developing, designing, producing, or supporting equipment in a cGMP environment required
- Knowledge of statistics, process control, quality engineering, sampling requirements, statistical techniques and process capability
- 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.).
- Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders and technical leaders.
PREFERRED QUALIFICATIONS
- Vision system experience with Syntegon, Seidenader, Innoscan, or other AVI vendors.
- Knowledge of Aseptic techniques and processing
PHYSICAL/MENTAL REQUIREMENTS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Up to 35% overnight travel including international locations
- Variable working hours as needed to support global footprint from US to Asia
OTHER INFORMATION
- This position is not relocation eligible
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Variable working hours as needed to support global footprint from US to Asia
- Up to 35% overnight travel including international locations
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $116,000.00 to $193,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email
disabilityrecruitment@pfizer.com
. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Engineering