Technical Lead, Manufacturing Applications, BTxPS

Technical Lead, Manufacturing Applications for Biotherapeutics Pharmaceutical Sciences (BTxPS) wanted by Pfizer in Andover, MA.

Role Summary

Lead the BTxPS effort to deliver and maintain effective manufacturing system workflows supporting the development of biological therapeutics, in partnership with the extended BTxPS digital core team.  This position will serve as the BTxPS Transformational Technology technical lead for BTxPS enterprise manufacturing systems (e.g. MasterControl Mx, AVEVA PI, Kynota). 

Role Responsibilities

• This lead will be responsible for implementing, supporting, and continuously improving manufacturing applications and data workflows from acquisition through to the creation of digital products/artifacts.
• Apply business knowledge to deliver on workflow optimization goals for Manufacturing Systems in alignment with BTxPS Digital Strategy and Good Manufacturing Practices (GMP) requirements.
• Represent BTxPS on digital projects with the goal of achieving efficient and consistent data workflows and compliance expectations. 
• Lead the adoption of manufacturing applications, including cloud-based Platforms (PaaS) and Software (SaaS), with consideration for GMP workflows.
• Develop any foundational plans required to support specialized automation and manufacturing.
• Develop Standard Operating Procedures (SOP) and supporting Solution Delivery Lifecycle (SDLC) documentation/processes to achieve compliance for GMP manufacturing systems.
• Design and execute plans for the ingestion, transformation, and analytics of manufacturing data into the Scientific Data Cloud (SDC). 

Basic Qualifications

Requires: Bachelor’s degree in Engineering, Electrical Engineering, Computer Science, or Life Sciences with 3 years related experience in job offered or as Automation Validation Engineer.

Also requires 3 years of experience with/using the following (which may have been gained concurrently):

• Understanding of biologics development and the various systems and platforms required for the development and manufacture of biologic therapeutics
• Working across business lines, evaluate complex business requirements, and develop harmonized business plans; SDLC experience
• Partnering with and managing vendor consultants/contractors
• Manufacturing Execution Systems (MES) such as Rockwell ControlLogix and GE Proficy applications
• Data Historians (e.g. OSIsoft / AVEVA PI); OSI PI; Integration Platforms (e.g. iPaaS / Boomi)
• GMP and non-GMP facilities, including cloud-based solutions in a regulated environment
• Databases and data management strategies
• Delivering analysis results using various visualization software solutions.

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.

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