Drug Product Injectable Manufacturing - Process Engineer

Pfizer Kalamazoo , MI 49001

Posted 2 months ago

ROLE SUMMARY

Provides technical expertise and operational support for B41 Injectables operation, with focus upon the manufacturing operations. Partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of human and animal health injectable products. Assists in equipment troubleshooting activities as needed.

ROLE RESPONSIBILITIES

  • The Process Engineer identifies and implements efficiency, safety, quality and/or cost improvements on equipment and processes. Possesses the ability to critically analyze Drug Product manufacturing processes for reproducibility, ruggedness, and root cause failure investigations of day to day operations.

    Requires developing strategies and systems to improve process performance. Ability to work in cross-functional teams with focus on deliverables, timelines, and meeting customer expectations and requirements. Exercises judgment within defined procedures and practices to determine appropriate actions, Uses rigorous logic and methods to solve difficult problems with effective solutions.

    Implements corrective actions and coordinates activities in conjunction with the appropriate enabling groups, i.e. engineering, quality, maintenance, operations, etc. Acts as customer project manager on select engineering projects. Partners with engineering to deliver projects that meet scope, schedule, and budget while fulfilling the operational needs of the project.

  • The successful candidate for this position will interact with Injectable Manufacturing/Filling/Inspection/Packaging, Project Engineering, Maintenance, Quality Operations, DP Manufacturing Project Transfer Teams in the support of Drug Product manufactured in APS (Aseptic Processing North) and APN (Aseptic Processing South).

  • Candidate will lead Operational Excellence initiatives (i.e. Kanban, M1 investigations, Green Belt certification, etc.) and routinely interact on the production floor and with Quality and Maintenance colleagues.

    Contributes to the completion of specific programs and projects. Failure to achieve results causes serious delays in meeting departmental objectives. Ensures that projects are completed on schedule following established procedures and schedules.. Leads and motivates others, generating commitment and a shared sense of purpose.

QUALIFICATIONS

  • BA/BS plus a minimum of 2 years' experience or MBA/MS plus a minimum of 1 years' experience in a science or engineering related field

  • Pharmaceutical or manufacturing experience and strong, demonstrated technical skills exhibited in a cGMP environment are requirements. Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.

PHYSICAL/MENTAL REQUIREMENTS

Candidate will be required to gown in order to enter higher classification area and execute responsibilities according to departmental procedures. Will work with biologicals, API, control substance and other drug products as required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Minimal travel may be required in order to support FAT (Factory Acceptance Test) or required training activities.

ORGANIZATIONAL RELATIONSHIPS

Production Floor, Master Scheduler, TL/Supervisor, Product Quality, Project Managers, Validation, Qualification, External Vendor, Injectables Manufacturing/Filling, Maintenance, Qualified Utilities, Contractors, Human Health Labs, and various levels of Management.

Some contact with outside organizations and customers. Represents the organization in providing solutions to difficult issues associated with specific problems.

Interacts with middle manager internal and external personnel on matters requiring coordination between areas. Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher and normally involves specific phases of a project or operation. Accomplishes daily operational tasks mainly through direct supervision of OTE and entry-level staff colleagues.

Persuades others to a point of view. Works collaboratively with others to gain agreement on a course of action.

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.

  • Last Date to Apply for Job: March 19, 2019
  • Additional Location Information: Kalamazoo, MI
  • Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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