Pfizer Mfg. Process Engineer in Sanford, North Carolina
Investigates manufacturing discrepancies to determine corrective actions. 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.
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. 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 a SME in areas of expertise by evaluating various manufacturing systems as related to Fermentation, Purification, and Conjugation processes including dispensing.
BS degree in Life Science (e.g. biology or Chemistry) with seven to 10 years of manufacturing experience in a FDA regulated industry or MS with four to six years of manufacturing experience in a FDA regulated industry.
Four to seven years working knowledge of vaccine or biotechnology product manufacturing in a GMP environment is preferred.
Utilizes available information, knowledge, and experience to make timely decisions to minimize impact
Applicable skills to guide colleagues during daily operations
Write clear concise summaries of investigations, product impact assessments, and commitments
Team based collaborative problem solving skills/understands root cause analysis (method 1)
Previous experience writing investigations within a GMP environment is preferred.
Capable of sitting and/or standing for extended periods of time during the work shift
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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- Last Date to Apply for Job: 24 October, 2018
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.