Supervision of aseptic filling and sterile subassembly operations and (union) operators. Responsible for the aseptic filling of all products assuring processes are performed in compliance with cGMP's and following Standard Operating Procedures (SOPs).
•Instructs the filling and subassembly operations of (union) operators in the daily duties and assures they are performed in a timely manner and in conformance with cGMP.
•Supervises operations to ensure adherence with all Safety requirements. Immediately addresses all safety events or concerns with Environmental, Health and Safety (EH&S) personnel. Responsible for 20-30 union colleagues per shift.
•Performs GMP audits of the aseptic processing area as required and investigates any process deviations; perform daily reviews of area batch records for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements.
•Composites new or revises departmental SOPs as required.
•Reports any significant shift activities to the Manager/TL; root cause analysis and ability to define effective corrective/preventative action.
•Coordinates personnel activities - i.e., vacations, sick time, etc. to ensure there is appropriate coverage in the department at all times; addresses personnel issues as they arise; trains new operators; conducts reviews with operators.
•Maintains inventory on materials and sterile items used in the aseptic processing area.
•Maintains and improves labor standards.
•Assist with the development and maintenance of the annual department overhead budget and orders supplies for area.
•Schedule shift to maintain hands-on support with operators; fill in for other supervisors as needed.
•Maintain communications with Work Team Enablers for batch records and SOP's: coordination of equipment maintenance and repairs with the Tech Services group; with QC Lab to coordinate laboratory testing; with Materials and Planning for scheduling of filling operations and ordering of materials; with Manager/TL to report daily activities and receive information on activities for the area; and with MQA for any quality issues/concerns.
•Assists the Manager/TL, Military Filling with special projects and other duties as assigned.
Education: Bachelor's degree in Engineering, Chemistry, Computer Science or other Technology or Life Science field.
Experience: 3-5 years previous supervisory experience required and/or combination of education and experience. Pharmaceutical or manufacturing experience highly desirable.
Language Skills: Effective written and oral communication skills required.
Computer Skills: Microsoft Applications, PLS, Trackwise.
Reasoning Ability: Demonstrated reading comprehension and writing proficiency at level that meets 'role' and/or 'test' requirements. Ability to effectively communicate within a diverse group resulting in desired outcomes.
Physical Demands: Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties. Additional requirements are line and product specific.(gowned) for substantial periods of time. Practices
Work Environment: Use of eye protection, gloves and other PPE is required. Maintaining aseptic area certification may be required. Aseptic gowning procedures will be required. Aseptic gowning requires all body parts to be completely covered and promotes safe working environment at all times.
Job task may include bending, twisting, and lifting items up to 35lbs at a frequency that meets position requirements. This position requires standing and frequent walking between production areas to supervise operations.
This position works around moving machines, is exposed to temperature changes and is required to wear personal protective equipment in certain areas and be gown qualified.
**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
Position requires regular on-site attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to email and phone communications and attending meetings. Note these activities may not be time bound to core hours or presence at the site.
Must have the ability to effective manage strict production, time and performance deadlines.
Must be willing to work beyond the hours typically defined as a 'regular' work day, which may or may not include weekends and holidays.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.
Last Date to Apply for Job: May 14, 2021
Eligible for Employee Referral Program
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.