1+ months

Process Engineer, Drug Product Supply

Groton, CT 06340
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We are seeking a highly motivated individual for the role of Process Engineer within Drug Product Supply (DPS) in Groton, CT. Our GMP facilities utilize advanced manufacturing technology to produce clinical supplies for Phase I - III studies. The Process Engineer has an integral role in technical project management to facilitate the manufacture and technology transfers of oral solid dosage forms. As a project lead you will liaise with cross-functional teams on technology transfers, prepare GMP documentation, provide operational oversight, and ensure on-time manufacture, testing and release of clinical supplies. This position is focused on the Continuous Manufacturing platform for solid dosage forms.


**Manufacturing Technology Services / Project Management:**

+ Represents Drug Product Manufacturing on multiple cross-functional project teams across the portfolio to coordinate the clinical manufacture of oral solid dosage forms (ie, immediate release tablets, modified release tablets, microspheres, and capsules), review data, capture lessons learned and present as relevant to work teams

+ Accountable for meeting team milestones/deliverables and helps forecast and plan resource requirements for advanced manufacturing projects across the department

+ Create/review/approve GMP documentation, including batch records, product specific cleaning assessments, and SOPs

+ Liaise with partner lines on tech transfer and manufacturing:

+ Rapidly translate lab scale formulations into robust GMP processes in partnership with formulators

+ Manage material requests (procurement and movement) with Inventory Management

+ Coordinate with GMP analytical lab and Quality Operations to ensure on-time test and release of clinical supplies

**Technology and Capabilities:**

+ Has comprehensive knowledge of new technology, procedures and job demands, remains knowledgeable of current technology, and identifies new tech trends

+ Facilitate knowledge management by sharing lessons learned with work teams, develop technical training or best practices, and exchange ideas with DPM leads and other Pharmaceutical Sciences project leads

+ Drive timely resolution of quality deviations and lead root cause analysis or CAPAs for manufacturing investigations

+ Individual contributor, but may review work completed by other colleagues and act in a mentor role

+ Provides technical guidance on production floor combining problem-solving and innovative techniques for production challenges and provide hands-on support as needed for set-up, cleaning process support, and batch record review

+ Leads operational teams to progress continuous improvement projects and new technology implementation

+ Provides excellent customer service using a variety of communication tools / techniques to inform on difficult concepts and provide real time project status updates

+ Makes decisions in non-standard situations, guided by adherence to cGMP compliance and data integrity requirements


+ BS/MS in a relevant Scientific or Engineering discipline and minimum 5 yr experience

+ Strong knowledge of industry practices for cGMP

+ Excellent communication and organizational skills

+ Self-motivated and regularly delivering towards timelines

+ Experience with solid dosage forms a plus

**Other Job Details:**

+ Eligible for Relocation Package: yes

+ 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.

Posted: 2020-05-01 Expires: 2020-07-02
Sponsored by:
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Process Engineer, Drug Product Supply

Groton, CT 06340

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