Principal Process Engineer, MS&T

Pfizer Inc. - Rocky Mount, NC4.2

30+ days ago
Individual contributor role within the Site Technical Services group at the Rocky Mount NC manufacturing site. This individual will bring significant experience in the areas of product development, manufacture of small and / or large volume parenteral products, or process improvement. Will serve as Subject Matter Expert in one or more technical areas and provide guidance and direction to junior member of the group.

Serve as a key scientific and technical representative for process related issues at the facility
Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards
Performing trending and monitoring of critical quality attributes, critical process parameters to maintain product quality and to control process drift
Identifying and implementing potential process improvements in conjunction with manufacturing operations
Participating in the start-up of new facility, equipment or processes in manufacturing
Assisting in documenting changes / updates to manufacturing [processes and working with manufacturing, engineering and validation to implement these changes
Reviewing and providing feedback and technical / scientific support on project deliverables
Establishing small scale production processes and using scaled down laboratory processes to enable process troubleshooting
Managing product transfers to and from the site
Execute laboratory studies and writes technical reports summarizing laboratory results to support product impact assessments required for investigations into process discrepancies or out of specification test results
Participates on technical teams for discrepancy investigation resolution, equipment or process validation activities, training on new process technologies and on significant changes to manufacturing procedures
Proposes process improvement opportunities and / or corrective actions to increase yield, maximize production capacity, reduce product costs and decrease process variability while maintaining regulatory compliance
Conduct process overview training to support implementation of new process technologies and assists in defining the scope of new capital projects
Collaborates with technical staff to implement process technology initiatives

BS in Engineering or Science required
Minimum of 10 years of experience in product development, manufacturing science and technology, sterilization or process validation or process engineering within the pharmaceutical industry required
7 years of experience working in a pharmaceutical manufacturing site
Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements
Excellent communication skills and attention to details

Master’s or PhD degree in science or engineering preferred
Experience with aseptically filled or terminally sterilized small volume and / or large volume parenteral products
15 or more years of experience in product development, manufacturing science and technology, sterilization or process validation or process engineering within the pharmaceutical industry
12 or more years of experience in a pharmaceutical manufacturing site

Able to stand for extended hours for test runs
Able to climb ladders/steps
Able to lift items of up to 25 lbs
Must be able to effectively communicate with others

May require off shift work to support engineering studies or batches in production environment
May require some travel to alternative manufacturing site for process observation or meetings
Weekend support may be required as dictated by project schedule, or customer need
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.

Other Job Details:
Last Date to Apply for Job: November 19, 2018
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.