Senior Associate Process Engineer, Gene Therapy Manufacturing

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.
Pfizer Sanford, NC site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products. This position will support the Pfizer Sanford Manufacturing Quality Assurance department by performing Quality activities associated with Gene Therapy (GTx) manufacturing operations.
How You Will Achieve It

• Collaborate with technical services to identify and confirm Critical and Key Process Parameters essential for Equipment and Process Validation.
• Report team progress, highlight risks, clarify issues, suggest recommendations, and present next stage development plans.
• Provide support to operations with various process equipment such as cell culture, recovery equipment, and depth filtration equipment, formulation and finish, and coordinate daily activities of Good Manufacturing Practices (GxP) production to meet supply chain needs.
• Facilitate effective project meetings with internal team members and customers, and develop SPC charts for continuous process monitoring and control.
• Manage project finances, continuous improvement projects, provide information to support financial reporting requirements, and ensure process adjustments are incorporated into final SOPs, Master Batch Records, and Compounding Records.
• Provide troubleshooting and technical support to manufacturing groups, participate in process and cleaning validations, adhere to site safety standards, change management, and enforce safety and biosafety requirements in the manufacturing department.

Qualifications
Must-Have

• Applicant must have a Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0+ years of experience; OR an Associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Experience in automation including DeltaV and equipment validation.
• Demonstrated knowledge of Good Manufacturing Practices and experience in a pharmaceutical environment.

Nice-to-Have

• Proficiency in project-oriented admin, cost control, and management
• Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes
• Experience in facilitating project meetings and managing project finances
• Commitment to safety and compliance with biosafety requirements

Physical/Mental Requirements

• Position requirements are typical for an office-based work environment with some lab floor exposure and clean room gowning will be required.
• Ability to work on own initiative.
• Strong technical management and organizational skills
• Good leadership and communication abilities
• Strong problem-solving skills

Non-Standard Work Schedule, Travel, or Environment Requirements

• This role is standard day Monday through Friday (8 hrs), but at times it will be necessary to work according to the manufacturing shift schedules (1st, 2nd or 3rd shift, weekends) to support execution of batch records when manufacturing batches that are manufactured outside.
• Limited Travel 10%.

Other Job Details:

• Last day to Apply: January 28th, 2025
• Eligible for Relocation Assistance: No
• Work Location Assignment: On Premise

The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. 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.
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.
Engineering
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