Hiring company: Pfizer
ROLE SUMMARY
This is a global role as a subject matter expert providing visual inspection process and compliance expertise to support Pfizer Global Supply sites and external partners. The primary purpose of this role is to provide strong compliance and VI process support as well as technical leadership in the deployment of innovative solutions in support of the Global Sterile Injectables and Biotechnologies Operating Units.
This role will report to the Director, Visual inspection to support strategic initiatives and understand 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 processes and systems by:
Partner with Director, Visual inspection to propose and lead strategic initiatives to support business objectives.
Provide comprehensive process and technical support across the manufacturing network including coordination with global technology suppliers.
Lead solution development and technical requirements for diverse product portfolios.
Develop and maintain comprehensive process performance documentation for all visual inspection processes to be available for audits and submissions.
Develop and Lead strategic visual inspection projects and programs to optimize network resources and costs.
Coordinate the development of worldwide visual inspection specifications that maintain product quality and compliance. Develop processes to maintain and control the visual inspection requirements.
Provide technical leadership during Audits; including back room, remote and front room support as needed
Work with Procurement and Supplier Quality to qualify and manage regional and global suppliers and the specifications required to support manufacturing.
Ensure timely completion of site support projects to achieve Pfizer goals
Educate and train Pfizer resources on use, functional capabilities, and limitations of Pfizer visual inspection.
Work with Quality, Regulatory and Operations management to ensure compliance to global regulations.
Provide technical support and project leadership to equipment vendors and related plants in resolving problems and assuring the corrective actions will minimize a reoccurrence of the problem.
Lead discussions with equipment vendors related to network business needs.
Is a recognized Subject Matter Expert in Visual Inspection and Container Closure Integrity Testing technologies and quality/compliance requirements.
Provide troubleshooting, root cause analysis serving as scientific and technical subject matter expert on issues that affect Visual Inspection and Container Closure Integrity
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 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 be lead strategic projects with large multi-discipline teams by developing strategy and leading team through project completion.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
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
Knowledge of Aseptic techniques and processing
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
ORGANIZATIONAL RELATIONSHIPS
Collaborate with other Global Engineering groups and leaders, and other technical groups in GTS, MAS, PGS sites
Represent Pfizer on multi-pharmaceutical industry SMEs network (Biophorum-BPOG, PDA, ISPE, 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.)
OTHER DETAILS
- Last Date to Apply: November 4, 2021
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.
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.