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Sterile Process Specialist 1st shift

Pfizer


Location:
Rochester, MI
Date:
10/27/2017
2017-10-272017-11-25
Job Code:
1052268
Pfizer
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Job Details

Job Title Sterile Process Specialist 1st shift

JobID 1052268

Location: Rochester, MI

Description A career at Pfizer offers opportunity, ownership and impact.



All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



The Sterile Process Specialist (SPS) is responsible for the manufacturing (micronizing, formulation and filling) of aseptic products. In addition, the selected candidates will be responsible for cleaning, preparing and sterilizing equipment and components needed in the manufacturing of aseptic products. Strictly following procedures, guidelines and site policies is a requirement of the position.



The essential duties for this position include but are not limited to:

• Performs all tasks as outlined in batch records, procedures, and job aids. Legibly records data in batch records, logs and other GMP documentation.

• Verifies materials and equipment against the batch record and assures materials are correct and approved.

• Supplies components, equipment and miscellaneous items to the manufacturing area as needed to maintain the production schedule.

• Performs checks, calculations and completes documentation as required to comply with procedures.

• Operates, cleans, lubricates, services, and makes minor repairs/adjustments to production equipment.

• Labels, dispenses and samples materials. Performs calibration verifications on production equipment.

• Accurately weighs, measures, mills and dispenses ingredients in accordance with batch records and procedures.

• Cleans and sterilizes process equipment using clean-in-place (CIP) and steam-in-place (SIP) systems.

• Assembles, operates, cleans and troubleshoots micronizing, formulation and aseptic filling equipment.

• Cleans, assembles, prepares and sterilizes equipment.

• Maintains a high level of cleanliness and housekeeping of all manufacturing areas.

• Performs other duties as assigned by supervision

General Expectations

• Work in a safe manner and report all potential safety issues to leadership in a timely manner

• Perform all tasks in strict compliance with operating procedures, best practices and regulatory requirements

• Dependable - Follows unit / area / plant requirements and guidelines

• Willing to assist other production units in order to meet unit / site goals

• Maintain training at or above 95%

• Perform a variety of miscellaneous tasks in support of the Rochester Site objectives



Communication and Leadership Expectations

• Consistently displays Own-It behaviors in accordance with Pfizer Core Competencies: Seizes accountability; grows self; change agile; self-awareness; commits to one Pfizer; peer relationships.

• Train and mentor new colleagues and contracted resources

• Provide feedback to leadership regarding issues and errors with GMP documentation.

• Understands basic problem solving methods (Method 1 training)

• Coordinates with maintenance to complete repairs and develop solutions to equipment issues.



High school diploma / general education degree (GED) plus either an Associate's degree or six months of work experience (e.g. current or previous Pfizer colleague; Mfg., Pkg. or Veterans/Military relevant experience). Math and reading skills required for SOP, GMP and Batch Record comprehension. Ability to contribute to department success in a team environment and perform tasks at a productive level under demanding conditions is mandatory. Must be self-motivated and willing to learn new and changing responsibilities. Requires a demonstrated ability to direct daily activities to meet production schedule.

Will be required to pass a basic skills test in order to be considered for this position



NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This is a second shift position with core hours from 3:00pm to 11:30pm Monday through Friday with overtime required as needed



OTHER

• This position is located in a penicillin facility. The candidates must not be allergic to penicillin.

• Must be able to fully gown in aseptic garb for extended periods of time.

• Considerable standing, walking, bending, reaching and lifting up to 50 pounds.

• Must be available to work extended hours and weekends if required to meet production goals.



**EEO Statement**

**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:**



+ **Pfizer/US/Non-Exempt/ Grade: 007**



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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