4 days old

Associate Process Engineer

Pfizer
Kalamazoo, MI 49007
**ROLE SUMMARY**

This position is for a Subject Matter Expert (SME) for Lyophilization (also referred to as Freeze Dry or Lyo) operations. The scope of the role includes support of Lyophilization related capital projects and operational support of existing Lyophilization operations. Key accountabilities include ensuring that the existing lyophilizers are functioning at an optimal state and that all new lyophilizers or modified lyophilizers function as intended to successfully manufacture drug products on schedule, ensuring all product is produced in a manner meeting safety and quality requirements.



**ROLE RESPONSIBILITIES**

Serves as subject matter expert on lyophilizer and/or automated loading/unloading systems. As responsible person for functionality of the lyophilization equipment, interfaces closely with operators, freeze dry leadership, maintenance, and quality to ensure the lyophilizers are functioning as intended. Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization. Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity. Investigates deviations that arise during lyo cycles. Performs root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety. Competent at reviewing lyo data trends to determine level of functionality of the equipment and processes to ensure all validated criteria are met and equipment is performing at optimal levels.



**BASIC QUALIFICATIONS**



+ Bachelor's degree in Engineering (Chemical, Mechanical, Industrial, Biomedical Engineering) or Life Sciences (Chemistry, Biochemistry, Microbiology).

+ 0-2 years of relevant experience.

+ Strong aptitude for learning process technology and equipment.

+ Excellent written and oral communication skills.

+ Demonstrated ability to interact effectively with all levels of the organization including diverse educational and cultural backgrounds.

+ Flexibility and ability to embrace and lead chance.

+ Ability to work in a high-paced team environment.



**PREFERRED QUALIFICATIONS**



+ Manufacturing experience with lyophilization equipment or unit operations common to lyophilization (wet/dry vacuum pumps, mechanical cooling, liquid nitrogen cooling, heat exchangers, and process control systems).

+ Experience in a cGMP environment including specific knowledge of and experience with Drug Product processing and equipment is desired.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Frequent time in both manufacturing and office environments. The manufacturing environment includes equipment with moving parts.

+ Must be able to perform gowning requirements for entry in the manufacturing areas.

+ Requires lifting, sitting, standing, walking, stair climbing and roof access.



**WORK ENVIRONMENT**



+ Office environment, with frequent time in the manufacturing areas.

+ Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.

+ Use of hearing and eye protection is required.

+ Must be available to support 24/7 - 365 operation.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

The focus of the work is at the Kalamazoo, MI site, however 0-10% travel may be required to support Factory Acceptance Testing and/or network support.



**OTHER DETAILS**



+ **Last Date to Apply: March 5, 2021**

+ **Eligible for Relocation Package**

+ **Eligible for Employee Referral Bonus**



**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.



Engineering



\#LI-PFE

Categories

Posted: 2021-02-22 Expires: 2021-03-24

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Associate Process Engineer

Pfizer
Kalamazoo, MI 49007

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