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API Manufacturing Specialist


Kalamazoo, MI
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Job Details

Job Title API Manufacturing Specialist

JobID 1615910

Location: Kalamazoo, MI

Description The successful candidate will assume professional responsibilities within the API (Active Pharmaceutical Ingredient) compliance group. Primary responsibilities include managing all cleaning and process validation activities for their assigned manufacturing areas. In addition, the candidate must interface regularly with customer and regulatory auditors and take a lead role in evolving compliance programs with the API area. Key responsibilities include:

+ Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.

+ Support 24/7 plant operations with timely responses to complex validation concerns or cleaning failures

+ Defend the validation programs and strategies to customer and regulatory auditors.

This position is primarily 1st shift, but occasional off shift and weekend support is expected.

This position is being jointly posted in parallel with a Grade 2 and Grade 7 posting for the same position. Consideration will be given to hiring the most appropriate candidate for one of the three postings to fill the position. The position may be offered as a developmental position based on the experience and career objectives of the most qualified candidate.


+ **Education / Experience:**

+ High school diploma / general education degree (GED) and 5+ years related experience in Active Pharmaceutical Ingredient Manufacturing (or similar), OR

+ 1+ years with Bachelor's Degree in an accredited program in a relevant Engineering or science discipline.

+ **Computer Skills:** Microsoft Applications, willingness to learn and utilize SAP, QTS, QPSNT

+ **Physical Demands:** Frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access.

+ **Work Environment:** Office environment, with frequent time in the manufacturing. Use of hearing and eye

+ protection is required.

+ **Certificates, Licenses or Registrations:** None

+ **Technical Writing:** Demonstrated ability to write effectively with emphasis on technical content.

+ **Regulated Environment Acumen:** Understanding of how regulatory standard and guidance documents as well as evolving cGMPS impact pharmaceutical production.

**Problem Solving and Innovation:** Provide solutions to a wide range of difficult/complex problems. May refer to precedents and policies. Able to gather, analyze and interpret information and identify cause and effect relationships. Solutions are imaginative, practical, thorough, and in-line with organization objectives. Able to adapt and respond positively to situations and people in order to meet changing work unit priorities. Identify cost improvement projects. Operate within established HR policies and guidelines.

**Discretion, Latitude, Level of Independence:** Work under only general direction. Participate in determining objectives of assignments. Independently determine and develop the approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Administer policies & procedures that affect individual colleagues in assigned unit.

**Impact and Organizational Contribution:** Contribute to the completion of specific programs and projects. Ensure that projects are completed on schedule following established procedures and schedules. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources. Monitor and manage the efforts of colleagues to achieve delivery of short-term goals. Lead and motivate others, generating commitment and a shared sense of purpose.

**Time Span of Work:** Projects and tasks covering one month to three months deliverables or milestones; Progress of work measured monthly.

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.

This position is primarily 1st shift, but occasional off shift and weekend support is expected.

**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.

**Additional Offer Details:**

+ **Last Date to Apply for Job: November 1, 2017**

+ **This job is Pfizer/Exempt/US/Grade: 004**

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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