6 days old

Manufacturing Systems Specialist

Pfizer
Chapel Hill, NC 27514
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**ROLE SUMMARY**



Pfizer's Chapel Hill site is helping Pfizer to lead the health care industry in the rapidly expanding field of gene therapy. We are working to bring exciting new treatments into the clinic with the promise of changing patients lives.



Pfizer Chapel Hill partners with our process development groups to manufacture early clinical stage cGMP material, producing both drug substance and drug product material. The work environment gains team members exposure to numerous aspects of cGMP manufacturing while working at the clinical manufacturing scale. The small size of the Chapel Hill site necessitates a team focused culture, allowing for empowerment and ownership at all levels.



Gene therapy is a significant growth area within Pfizer's portfolio. Pfizer is committed to the success of Chapel Hill and has recently announced the purchase of a new clinical manufacturing facility. The new facility will more than double our current capacity as we continue to deliver new gene therapy treatments.



The Chapel Hill manufacturing facility is located on the edge of RTP right off Interstate 40. The new facility is located near the Interstate 40 and 540 intersection and is scheduled to open in 2021.



The Manufacturing System Specialist position provides a wide range of support to the manufacturing team. This multifunctional role will partner with both site-based operations and external project teams to ensure the delivery of early clinical stage cGMP material.



**ROLE RESPONSIBILITIES**



+ Own and support all aspects of manufacturing investigations.

+ Root cause investigations.

+ Product impact analysis.

+ Corrective and preventive action (CAPA).

+ Assist in implementing system level improvements, aligning to manufacturing, quality, and safety.

+ Create and revise GMP documentation.

+ Provide oversite of manufacturing process and coordinate data review activities with Process Development groups.

+ Provide support of technology transfers from Process Development groups and other external project teams.

+ Assist in managing process and facility related changes.

+ Work in electronic systems including Trackwise, LIMS, ERP (i.e. SAP/Axis 360), Process Automation systems (i.e. Delta V, Unicorn, Finesse), etc.

+ Additional responsibilities, as assigned.



**QUALIFICATIONS**



+ Bachelor's degree in Chemical Engineering or Science discipline with 0 -2 years of direct experience in biopharmaceutical GMP manufacturing.

+ Experience in problem solving methodologies.

+ Experience in technical writing.

+ Strong interpersonal, teamwork, and collaboration skills.

+ Ability to work in a cross-functional team environment with excellent written and verbal communication skills.

+ Experience working within electronic systems.

+ Excellent time management and multi-tasking skills.

+ Adaptability to changing work environment and priorities.

+ Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Must be able to gown into cleanroom environment when needed.

+ Must be able to perform complex data analysis.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Some travel may be required for training held at other locations.



**Other Job Details:**



+ **Last Date to Apply for Job: March 2, 2021**

+ Eligible for Employee Referral Bonus: YES



**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.



Research and Development



\#LI-PFE
Posted: 2021-02-19 Expires: 2021-03-22
Sponsored by:
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Manufacturing Systems Specialist

Pfizer
Chapel Hill, NC 27514

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