Associate, Manufacturing Technology Engineer

Pfizer Groton , MA 01450

Posted 1 week ago

The Chemical Research and Development group in Groton CT is seeking candidates for an Associate of Manufacturing Technology Engineer (MTE) role in the API Manufacturing group! This role is part of Worldwide R&D in Medicinal Sciences and is responsible for the development of process technology for the production of active pharmaceutical ingredients (API).

The Associate will take primary direction from a senior Manufacturing Technology Engineer. MTEs are involved in the design and deployment of novel equipment systems for the manufacture of clinical API supplies. In this role, MTEs primary responsibilities are to ensure that the "end user" perspective factors prominently in the evolution of innovative equipment designs, and to actively manage the facility integration of prototypes in compliance with local policies, procedures, and regulatory expectations.

The successful MTE is well-versed in design aspects of the manufacturing facilities (equipment, utilities, controls, procedures, workforce), understanding technical capabilities and limitations so as to properly advise the development and construction of equipment systems from conceptualization through realization. The MTE collaborates with engineers, chemists, and analysts to develop new equipment prototypes, then works with the operations team Global Operations to implement the new systems in the regulated manufacturing areas.

ROLE RESPONSIBILITIES

  • Develop and sustain profound familiarization with the technical design of the CRD manufacturing areas, equipment and utilities, the quality systems used in manufacturing, and the composition and workflows of the operations team.

  • Integrate effectively into the Flexible API Supply Technologies (FAST) initiative, providing manufacturing and design insight into the evolution of new API manufacturing platform technologies, such as Plug Flow Reactors, Gas/Liquid Flow Systems, Liquid/Liquid Extraction Systems, Continuous Isolation and Drying Technologies, etc.

  • Work with Engineering, Operations and Environmental Health & Safety (EHS) representatives to ensure that a scale and facility-relevant Process Safety protocol is used to identify and mitigate safety risks associated with new equipment systems.

  • Coordinate the transition (technology transfer) from laboratory demonstration to manufacturing deployment, leveraging partnerships with Maintenance, Procurement, EHS, and Quality Assurance to create effective project management plans for system roll out.

  • In concert with the operations team, develop commissioning protocols, standard operating procedures, and cleaning approaches specific to the new equipment systems.

  • Manage timelines in response to portfolio and technology demand prioritization.

  • Effective communication skills to update stakeholders of project status.

  • Supervise operations personnel in the commissioning and use of the new equipment systems, which will typically be integrated to work in sequence with existing batch technologies.

  • In quick order, complete After Action Reviews for each instance of equipment deployment to ensure that learnings and opportunities for improvement are factored in to the future development and implementation of said technology.

BASIC QUALIFICATIONS

  • Bachelor's Degree in relevant engineering discipline (Chemical, Mechanical, Pharmaceutical) with 0-2 years of experience.

PREFERRED QUALIFICATIONS

  • Familiarity with current Good Manufacturing Practices (cGMPs) and prior experience in a manufacturing operations and project management are highly desired.

  • Mechanical aptitude a plus as this is a "hands-on" engineering role.

  • Ideal candidate will have also through the course of study, research, or prior employment contributed to the development and testing of prototype mechanical systems and have knowledge and experience working with process control methodologies.

Other Job Details:

  • Additional Location Information: Groton, CT
  • Eligible for Employee Referral

    Bonus:
    Yes

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.

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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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Associate, Manufacturing Technology Engineer

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