Manager, Process Engineering – Vaccine Sterile Inspection

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will be using your extensive management skills to successfully support the production process.  You will drive the efficiencies of the overall manufacturing systems impacting quality operations of their respective area of operation, including maintenance, batch record, manufacturing quality, reliability, training, etc. 

As a Manager, you will be setting the objectives for multiple projects in your division. Your managerial and organizational skills will help in guiding the people in your division in time management and overall operations. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the division and sets direction for its success.

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

Provides technical expertise and operational support for Drug Product Operations, with focus on Vaccine Sterile Inspection Operations. Partners with shop floor colleagues and supervision to ensure safe, compliant, and efficient inspection of a diverse mix of injectable products. Assists in equipment and process troubleshooting activities as needed. Serves as a key technical subject matter expert within the site for inspection technologies. Responsible for technical development of junior colleagues.

How You Will Achieve It

• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division.
• Effectively manage and coordinate manufacturing technical processes and functions at the site in support of technical projects.
• Identify and implement cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
• Incorporate Current Good Manufacturing Practices regulatory and safety compliance into all assigned projects' scope and design.

Role Responsibilities

• Conducts tests and measurements throughout stages of inspection to determine control over applicable variables, including tuning of visual, physical, and spectroscopy-based inspection systems.
• Investigates deviations of high complexity, involving multiple departments/sites, with significant scope that occur on the manufacturing floor. Performs root-cause analysis using Six Sigma tools, and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety. 
• Authors and performs periodic reviews of unit/divisional/site documentation, including SOPs, User Guides, Job Aids, etc., and gathers input from cross-functional team members to ensure safe, efficient, and compliant practices.
• Supports safety team by proactively identifying improvement opportunities and implementing engineering, protective, and procedural controls to improve the safety of colleagues working in the area and ensure compliance with applicable regulations.
• Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization, and uses Six Sigma tools to investigate common cause process variation.
• Responsible for training operations colleagues on aspects of equipment operation.
•  Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity. 
• Develops and validates manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site.
• Responsible for audit preparation, documentation, follow up for unit operations.  Present investigations, procedures or practices to auditors, and acts as an SME for tours and discussions.  Responsible for developing compliance gap assessments and responses for Pfizer Quality Standards or for Regulatory Observation Network Assessments, and for developing strategies for complying with evolving compliance expectations. 
• Contributes to master planning exercises by maintaining matrices of unit capabilities, gaps, and needs.  Applies expertise of product/technology compatibility for feasibility assessments.
• Contributes SME knowledge on emerging technologies and develops and shares best practices with PGS network or industry communities of practice.
• Serves as a key site technical SME for automated visual inspection technologies, and other key physical or spectroscopy-based inspection technologies.  Responsible for technical development of junior colleagues.

Qualifications

Must-Have

• Bachelor's Degree
• 5+ years of experience
• Demonstrated ability to contribute to and lead project teams
• Demonstrated ability to interact effectively with all levels of the organization
• Strong verbal and written communication skills
• Specific knowledge of and experience with sterile inspection practices, processes, and equipment are required. 
• Pharmaceutical and manufacturing experience, and strong, demonstrated technical skills exhibited in a cGMP environment are requirements.

Nice-to-Have

• Master's degree
• Relevant pharmaceutical industry experience
• Six Sigma Black Belt certification preferred.
• Experience across multiple departments/functions is highly desired.

 
Physical/Mental Requirements

• Gowning to access production floor will be required.
• Ability to troubleshoot complex automated systems is required.
• Mature project and presentation skills and financial and business acumen are required.

Non-Standard Work Schedule, Travel or Environment Requirements

Travel may be required for specific projects, training, or network support.  Job may also require occasional weekend/evening work supporting a 24-hour/7-day operation.

Other Job Details:

Last Date to Apply for Job:  December 17. 2021

• Eligible for Relocation Package
• 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.

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.

Manufacturing

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