Manager Process Engineering - Vaccines
Job Description
Why Patients Need You
Responsible for the technical oversight of process equipment / systems, manufacturing operations, and automation control (Delta V, etc.). Manage multiple projects, within cGMP/regulated guidelines working across multiple functions internally and externally, related to process requirements and evaluation of equipment and systems to ensure deliverables meet or exceed process specifications and manufacturing requirements. The position will have direct reports that work on multiple shifts to oversee 24/7 biological manufacturing operations. Must make key decisions and act decisively when opportunities arise.
Will report into the Director of Manufacturing Support. Direct reports will be 8-12, will lead cross functional project teams of various scope and duration amd will lead and interact with cross functional site teams.Teams will be made up of other people leaders and professional individual contributors. Will interact daily with the manufacturing teams and their management. Interaction with support groups that provide services and support to the manufacturing process.
Will interact with external groups such as engineering consultants, construction management firms, and external suppliers.
How Will You Achieve It
Technical oversight of cGMP area specific equipment and processes that will be required for new and existing products. Candidate would be responsible for managing projects and commitments that would improve processing and processing robustness. Programs could originate from continuous improvements and new product lines and investigations.
Strong decision making on issue resolution that impact cGMP regulated processes and equipment.
Lead and develop a team of Manufacturing engineer/scientists to support 24/7 biological manufacturing operations.
Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise, and coach their teams.
Review the content of all Leader Led Conversations and, on an annual basis, conduct two ‘Leader Led Conversations’ with their teams aimed at fostering a culture that supports compliance with procedures, including good data management.
Qualifications
Must have:
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associate's degree with 8 years of experience OR a Bachelor's degree (in Engineering or Science preferred) with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
Experience in pharma or other regulated industry
Advanced knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area.
Ensures that work performed is accurate, timely, efficient, and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations.
Strong decision-making skills
Engage and inspire their teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
Effectively monitor the actions of their team. Ensure an active daily presence in the GMP work area to observe the work activity and practices within their role responsibilities.
Be accountable for the Good Data Management and Data Integrity understanding and performance of their team.
Be available to their direct reports for real time escalations of any concerns or support needs.
Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
Lead and support continuous improvement efforts, where applicable.
Be a role model to support a positive compliance culture.
Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
Nice-to-Have:
Process Development and/or validation
Project management
Technical oversight of cGMP area specific equipment and processes
Physical / Mental requirements
Ability to work in a clean room environment. Ability to sit at a desk for long periods of time.
Non-Standard work schedule, travel or environment requirements
Some weekend and night work may be needed from time to time but not routine.
Other job details
Last day to apply: November 5th, 2024
Work Location Assignment:On Premise
No relocation support available
Relocation assistance may be available based on business needs and/or eligibility.
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 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.
