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

The annual base salary for this position ranges from $109,400.00 to $182,300.00. 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.

Relocation assistance may be available based on business needs and/or eligibility.

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