Injectable Freeze Dry Operators are responsible for the operation of Freeze Dryers of B-41’s injectable drug product areas (Aseptic Processing North & South facilities). Work is performed in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e., GMPs & OSHA). This job includes the following functions: aseptic gowning and personnel monitoring, processing of hazardous and non-hazardous drug products, computer skills, operating PLCs and SCADA systems, physical material handling (handling trays with product), assisting/preparing equipment for troubleshooting and completing GMP documentation. Colleagues are expected to share best practices with other colleagues on their shift, and across shifts.
In addition to freeze dry area, colleagues might be required to work in other areas, such as Injectable Filling, Inspection, or Packaging, as production demands require. Over-time and weekend work as production demands will be required.
ROLE RESPONSIBILITIES
Specific job functions include:
Identifying and seeking to implement process and safety improvements
Executing in-process quality inspections
Recording GMP entries in batch record
Working in filling areas if required
Following all safety procedures (LOTO, Confined Space & Safe Work Permit)
Perform turnaround cycles (manual clean or CIP, SIP or VHP)
Developing corrective and preventive actions
Seeking value added tasks during unplanned line downtime
Completing and maintaining all required training on time
Other duties as assigned by the supervisor
Working under Aseptic conditions as schedule
Support execution of Capital Projects
QUALIFICATIONS
PHYSICAL/MENTAL REQUIREMENTS
OTHER INFORMATION
Working Primarily 2nd shift (3:00 pm to 11:30 am) - Weekend, Holiday and overtime may be required.
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:
Additional Location Information: Kalamazoo, MI
Eligible for Relocation Package