Digital Controls Specialist, Clinical Manufacturing

WHY PATIENTS NEED YOU

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in -class medicines to patients around the world.

WHAT YOU WILL ACHIEVE

The Digital Controls Specialist (R5) will be joining the Pfizer Andover Clinical Manufacturing Facility (ACMF) team.

The ACMF is a facility located on the Pfizer Andover, MA campus and isresponsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The ACMF resides within the Research and Development organization.

The Principal Digital Specialist will join the ACMF as a subject matter expert in automation controls, data management, electronic systems and digital solutions. The role will initially focus on electronic batch record implementation in the ACMF. This EBR rollout is expected in mid-2022. After EBR implementation, the Principal Digital Specialist will support the ACMF as an EBR, Delta-V automation expert as well as contribute to any other digital / automation projects that arise.

HOW YOU WILL ACHIEVE IT

• Create and modify Delta-V automation recipes for in-bound ACMF manufacturing campaigns (with support from the ACMF Tech Transfer team)
• Serve as the ACMF conduit to the Pfizer Digital Team for local implementation / execution of Digital projects
• Lead implementation of Electronic Batch Records (EBRs) in the ACMF
• After EBR deployment in ACMF, serve as a primary point of contact for EBR troubleshooting assistance (during normal working hours only)
• Continuously modify and improve EBR templates in partnership with the ACMF Tech Transfer team
• Collaborate with other BTx Manufacturing facilities to harmonize best practices for manufacturing controls and digital solutions
• Serve as subject matter expert on data management to drive best practices in ACMF sharing of manufacturing and analytical data with key partner lines

BASIC QUALIFICATIONS

• BS/BA in Computer Sciences, Computer Engineering, Chemical Engineering, Biotechnology, or equivalent discipline + 7 years of experience.
• Previous experience in manufacturing control systems (ideally Delta-V)
• Previous experience in cGMP Biologics manufacturing
• Fundamental understanding of Biologics Drug Substance manufacturing unit operations
• Proven ability to troubleshoot complex processing issues and ability to make decisions with minimal guidance required.
• Strong verbal and written communication skills
• Experienced with electronic systems including QTS (i.e. Trackwise), Documentation, LIMS, ERP (i.e. SAP/Axis 360), MMS/Maintenance, Process Automation systems (i.e. Delta V, Unicorn, Finesse), and other business systems (Microsoft Word, Excel, etc.)
• Proven ability to make risk-based decisions in a complex/dynamic environment in a timely manner.
• Experienced in authoring cGMP documentation including SOPs and Batch records.
• Strong collaboration and partnership skills-able to work across functional areas such as development, maintenance, quality and regulatory functions in matrix environment.
• Ability to flex and quickly adapt to changing environment and priorities.

PREFERRED QUALIFICATIONS

• Ability to lead complex projects and tasks with limited oversight and supervision
• Advanced understanding of bioprocessing techniques and equipment
• Ability to identify and implement process improvements independently
• Advanced experience with Tech Transfer, Facility Fit assessments and engineering design
• Excellent oral and written communication skills

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work off shift (Nights and Weekends) as needed; non-routine
• Ability to work in a clean room environment

Other Job Details:

• Eligible for Employee Referral Bonus
• Eligible for Relocation

#LI-PFE

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.

Research and Development

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