Director, Global Engineering Technical Leader, SBO

Pfizer Inc.

Andover, MA

Job posting number: #7135246 (Ref:pf-4880834)

Posted: March 21, 2023

Application Deadline: Open Until Filled

Job Description

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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.

What You Will Achieve

This is a global role with the primary responsibility of leading a team of technical Global Engineering  Subject Matter Experts (SMEs )to provide process and equipment engineering solutions into the design and operational philosophy of the Sterile Injectables and Biotech (SBO) sites and external partners. 

The Director, Global Engineering Technical Leader, SBO will directly manage a number of Subject Matter Experts as well as being responsible for providing technical leadership and standardization to the SBO OpU.   They will also be a member of the GE SBO leadership team. This role has responsibility for building/maintaining effective matrix relationships with key partners in PGS (GT&E, Launch Excellence, Operating Units, Procurement, Quality, Supply Chain, Hospital Business Unit) as well as key equipment vendors.

How You Will Achieve It

  • Lead the Sterile Injectable and Biotech GE technical team which develop innovative solutions and ideas and provide  strong technical support to the SBO Operating Unit (OpU) and Contract Manufacturing Organizations (CMOs) to optimize process robustness and asset performance.

  • Provision of technical leadership / subject matter expertise on SBO manufacturing technology for :

    • New product sourcing strategic decision-making

    • Technical assessments of Contemporization and strategic Investments

    • SBO network strategy development

    • Technical Support to the GE Led Capital Projects

  • Partner with the GE SBO Cluster leads to ensure resources are deployed appropriately to meet the needs of the four cluster operating units within the SBO OpU

  • Partner with the internal GE Functional leads (e.g. Capital Project Execution, New Modalities, Global Engineering Operations, Automation) to ensure alignment of priorities and support to GE program deployments

  • Partner with GE Global Automation to assure Equipment Automation is in line with Automation Standards.

  • Partner with GT&E and Pharmaceutical Sciences on the development and introduction of innovative technical solutions and platform technologies.

  • Responsible for the implementation and adherence to the IMEx Operating model.

  • Leads the development of SBO technology standards and partner with relevant GE leaders to develop and  embed a robust process for standardization

  • Manage the teams Operating Budget

  • Manage the team resources to ensure :

    • Timely resolution of complex site technical issues which are impacting overall product performance and supply

    • Technical support to technology transfers (between/within the PGS network – internal/external)

    • Development and implementation of next generation and innovative manufacturing technologies

    • Support to the remediation of regulatory deficiencies e.g. Contemporization of equipment

  • Maintain the depth and engineering capability of the SME talent pool. Promote and drive the technical and personal development of the personnel.  Assure the number and skillsets of the resources are sufficient to serve the needs of the immediate customers of the group.  Take action to implement a model of resourcing that assures sustainability and consistency of the group’s activity and output.

  • Responsible for Vendor Relationships Management. Develop and strengthen partnerships with key vendors to facilitate issue resolution, after sales support, new technologies etc.

Qualifications

Must-Have

  • Bachelor Degree in Engineering or equivalent scientific discipline

  • Minimum 15 years in pharmaceutical  manufacturing, (biological drug substance manufacturing/aseptic processing/ engineering)

  • Strong knowledge of drug substance and/or drug product processes and equipment and its application in manufacturing  operations

  • Familiarity with relevant quality and regulatory requirements and trends and cGMP’s (e.g. FDA, EU Annex 1, PIC/S, PDA, ISPE, Pfizer PQS, etc.).

  • Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations and technical leaders.

  • Ability to lead technical teams, programs and initiatives, fostering support from stakeholders and collaboration among participants.

  • Proven ability to work in a cross cultural environment and provide technical  management while working remotely.

  • Appropriate business acumen to lead or provide guidance on equipment, processes, and capital investment strategies.

  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Nice-to-Have

  • MS or MBA desirable

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • International travel up to 30%

  • Adaptation of schedule to work across different time zones


Relocation support available

Work Location Assignment: Flexible

  • Other Job Details:

  • Last Date to Apply for Job: April 3, 2023

  • Eligible for Relocation Package:  Yes

  • Eligible for Employee Referral Bonus: Yes

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

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.

Engineering

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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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