Manufacturing Quality Engineer - 12 Hour Night Shift

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

The Manufacturing Quality Engineer provides oversight and guidance in SVP, LVS, Flex/Vis IV, and Part Fill manufacturing operations, ensuring continuous facility and GMP compliance. The MQ Quality Engineer will coach manufacturing personnel on proper GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure quality product.

• Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with GMP compliance and regulatory guidelines.
• Implement process improvements with a focus on quality processes.
• Provide input and decision making for quality on the shop floor with regard to manufacturing and deviations. Provide corrective action as necessary.
• Work closely with Manufacturing and other support functions to troubleshoot during unexpected events.
• Complete projects as identified by management.

• BA/BS required (science degree preferred).
• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.
• Strong oral/written communications skills and leadership skills required.
• Ability to work well with all levels of personnel throughout the facility.
• Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.

• Prior previous pharma experience preferred.

• Experience in a clean room environment desirable.

• Prior experience in sterile manufacturing and an understanding of the sterilization process and its impact to products

• Experience in a clean room

PHYSICAL/MENTAL REQUIREMENTS

• Stand up to 8 to 10 hours, sit up to 2 to 4 hours, occasionally lift a maximum of 20 pounds 3 times per shift, walking and climbing stairs, work around and close to moving equipment.
• Use computer terminal up to 6 hours per shift, respond to visual warning indicators, respond to audible indicators, respond to color or special visual indicators, work around moving equipment, work on knees occasionally, wear specialized protective clothing, wear PPE (safety shoes/glasses/etc), work in hot or cold environment, work in hearing conservation area.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• 12 hour Night shift 7 pm- 7 am, 3/2/2 rotating schedule
• Ability to work overtime as required supporting business needs.
• Ability to gown aseptically for entry into the Aseptic core areas.
• Ability to follow area specific gowning requirements for entry in to the Terminally Sterilized areas and/or other classified solutions/filling areas
• Ability to work off-shifts and/or weekends as required.
• This position is not eligible for relocation
  

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.