Job Description

ROLE SUMMARY

* Provides technical expertise and operational support for B41 Gelfoam manufacturing and packaging operations. Partners with shop floor colleagues and supervision to ensure smooth and efficient production of Gelfoam products. Key accountabilities include ensuring all equipment functions as intended to successfully manufacture product on schedule, and all product is produced in a manner meeting safety and compliance requirements(Pharma and Med Device).

ROLE RESPONSIBILTIES

* Develops and validates manufacturing equipment and processes in line with medical device regulations

* Conducts tests and measurements throughout stages of start-up and production to determine control over applicable variables.

* Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.

* Leads MDCP(Medical Device Combination Products) CAPA investigations

* Identifies and implements cost savings ideas, such as line efficiency improvements and other projects that increase equipment capacity.

* Serves as subject matter expert for current technology in the unit as well as future equipment purchases or improvements; interface closely with engineering to specify user requirements, review and approve drawings, define project scopes, develop and execute equipment acceptance testing and validation criteria.

* Investigates deviations that occur on the manufacturing floor. 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.

* Participate in cross-functional teams in the preparation of risk management documentation, including product impact assessments, risk analysis, hazard analysis.

* Successful candidate must be familiar with tools and techniques required to manage small scale, moderately complex projects through multi-disciplinary teams.

QUALIFICATIONS

Must-Have

* Bachelors degree in Engineering (Chemical, Mechanical, Industrial, Biomedical Engineering) or Life Sciences (Chemistry, Biochemistry, Microbiology) & a minimum of 2 years of relevant manufacturing experience OR a masters degree in engineering or science.

* Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding

* Working knowledge of Food and Drug Administration Regulations, Medical Device Regulations and Good Manufacturing Practices

* Proactive, has experience with high performance teams, strong interpersonal and project management skills

* Possess flexibility to respond to changing conditions and priorities.

* Strong written and verbal communication skills

* Microsoft Applications skills

Nice-to-Have

* Manufacturing experience with demonstrated technical skills related to medical device regulation

* Knowledge and experience with Drug Product processing and equipment

PHYSICAL/MENTAL REQUIREMENTS

Job will include standing, walking, bending and sitting. Occasional lifting may be required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Job will entail occasional weekend work

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 16, 2021
* 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 providers 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