Pfizer Freeze Dry Technician 3rd shift in Kalamazoo, Michigan

ROLE RESPONSIBILITIES

Freeze Dry Tech I position is responsible for providing technical training and equipment troubleshooting assistance to work team colleagues. Proficient in working with complex computerized manufacturing systems. Ability to diagnoses operating difficulties troubleshoots equipment problems, work with Maintenance and other enabling groups with repairs of repetitive equipment failures. Serve as liaison between work team and enabling groups for equipment repairs, preventative maintenance and capital projects coordination. Assist in the development and training of work team colleagues on team initiatives such as operator care and freeze dry equipment/process troubleshooting. Establish efficient processes, monitoring specific results, and improve identified process opportunities using Right First Time (RFT) and Lean principles (i.e. 5S or Standard Work). Monitors & maintains manufacturing equipment at optimal operating efficiency. Assists in identifying problems and solutions using Method 1 and Quality Risk Management (QRM) tools. Assists the Deviation Report Coordinator (DRC) on equipment related deviations and corrective action implementation (QTS). Work with engineering by participating, capital scope development, FAT/SAT support, qualification activities and coordination of project execution. Create EAMS work orders for equipment and facility repairs. Also responsible for supporting the operations work teams to ensure that applicable unit and site safety guidelines/policies are followed. All tasks are conducted in accordance with appropriate processing standards, such as FDA's current Good Manufacturing Practices (cGMP's).

Additional job functions includes:

  • Ensure work team operates under site safety guidelines. Update/train work team regarding safety systems such as LOTO, Confined Space and Safe Work Permit.

  • Ability to perform safety assessments of routine and non-routine activities

  • Assist in the implementation of quality and safety related corrective and preventive actions

  • Assist on Capital Project execution

  • Assist maintenance and other enabling groups identifying solutions of frequent equipment failures

  • Develop/Implement total productive maintenance and/or operator care tasks for work team

  • Identifying and implement process and safety improvements

  • Update/create documents such as SOPs, OJTs, Job Aids, etc.

  • Create EAMS work orders for equipment and facility repairs.

  • Performs task defined for a freeze dry operator such as;

  • Load and unload trays of product into and from freeze dryers and deliver to filling lines

  • Input data into complex automated control systems on several types of freeze dryers & product transfer carts

  • Operate fully automated equipment for freeze dry unloading.

  • Review freeze dry cycle charts or batch end reports and make GMP decisions on quality of run

  • Wash, sanitize and operate transfer cabinets, carts and loaders

  • Demonstrating ownership and accountability to production schedule and protecting product quality

  • Monitoring freeze dryers for efficient run time versus established standards

  • Ensuring adequate inventory of parts and materials prior to initiating a production run

  • Recording GMP entries in batch record

  • Perform turnaround cycles (manual clean or CIP, SIP or VHP)

  • Work under aseptic conditions

QUALIFICATIONS

  • Education and Experience: High school diploma / general education degree (GED) plus either an Associate's degree or six months' work experience (e.g. current or previous Pfizer colleague or Pfizer's contractor; Mfg., Pkg. or Veterans/Military relevant experience).

  • Minimum of 2 to 3 year of experience in Freeze Dry area.

PHYSICAL/MENTAL REQUIREMENTS

  • Physical Demands: lifting/lowering up to 55 pounds/ reaching/ standing/walking/stooping/climbing/crawling/working in high elevations (above 6 feet).

  • Able to wear safety PPE (Hard hat & body harness)

  • Able to work in fully cleanroom gowning uniform

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Working Primarily 3rd shift (11pm to 07:30am). Variable shifts may be required based on business needs, Weekend, Holiday, and Overtime may be required to meet business or customer needs.

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: July 27, 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.