Mfg Process Engineer, Investigator

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Sep 21, 2020
Ref
4792557
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

This is a Manufacturing Process Engineer, Lead Investigator position within Vaccines Production Operations.

Conducts all activities and makes decisions that are in accordance with Company policies and SOPs, Pfizer Values, and global regulatory guidelines (including cGMP/cGLP), environmental guidelines, as appropriate, etc. Advise management of non-conformance issues and opportunities for continuous improvement via data trend analysis, interpretation of data, gap analysis and implementation of corrective activities. Provides input on SOP's, batch records, forms or other cGMP related documents developed or revised to support continuous improvement efforts and regulatory audit commitments. Investigate manufacturing discrepancies to determine corrective actions.

Proactively identify areas for improved efficiencies and ensure that product quality is maintained through all phases of commercial production including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics, and integrated utilities to identify and resolve quality risk to commercial manufacturing. Serve as an SME in areas of expertise by evaluating various manufacturing systems as related to Fermentation, Purification, and Conjugation processes, including dispensing. Requires general knowledge of scientific principles, technical knowledge of production equipment and related procedures with emphasis on assigned production area. Capable of identifying technical problems and solving them with minimal guidance of supervisor. Ability to analyze operational process problems and recommends appropriate corrective and preventative actions. Provides technical guidance and acts as a departmental liaison with primary support groups such as engineering, technical services, quality control, quality assurance, development and utilities.

BASIC QUALIFICATIONS
  • BS degree with minimum 3 years of manufacturing or quality experience in an FDA regulated industry OR MS with minimum 1 year of manufacturing or quality experience in an FDA regulated industry.


PREFERRED QUALIFICATIONS
  • BS degree in Life Sciences or Engineering preferred
  • Experience writing clear concise summaries of investigations, product impact assessments, and commitments
  • 3 years of working knowledge of vaccine or biotechnology product manufacturing in a GMP environment is preferred.
  • Team based collaborative problem solving skills/understands root cause analysis (Method 1)
  • Applicable skills to guide colleagues during daily operations
  • Utilizes available information, knowledge, and experience to make timely decisions to minimize impact


PHYSICAL/MENTAL REQUIREMENTS
Capable of sitting and/or standing for extended periods of time during the work shift.

OTHER INFORMATION
  • Last Date to Apply: 10/5/20
  • Eligible for Employee Referral Bonus
  • #LI-PFE


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