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Sr Validation Engineer

Pfizer


Location:
Andover, MA
Date:
09/22/2017
2017-09-222017-10-21
Job Code:
1611599
Pfizer
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Job Details

Job Title Sr Validation Engineer

JobID 1611599

Location: Andover, MA

Description Develop/lead and execute program around equipment and facility validation in a biological manufacturing environment



Role Description

This position will provide support for the Equipment Validation Program and Validation projects at Pfizer Andover site. The ideal candidate will develop/lead and execute validation program around equipment and facility validation in a biological manufacturing environment

The Sr. Validation Scientist / Validation Engineer is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to define, standardize and support the validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.

The incumbent in this position will be responsible for supporting and implementing the established validation approach and is accountable for supporting the site's successful adherence to the Validation Master Plan, Validation SOP's, and the integration of the Master Plan with the Strategic Planning Process.



The incumbent will be expected to partner with the SME's of the site Quality Assurance Validation group to ensure all validation strategies and validation executions meet all applicable Pfizer quality and compliance standards, local SOP's, as well as applicable regulatory standards. The incumbent will be responsible for providing Validation supporting during regulatory inspections. The incumbent will support the development, implementation and maintenance of system(s) for tracking and measuring validation status, resource utilization and effectiveness.



The Validation Scientist / Validation Engineer will also be responsible for supporting the development the next generation validation program.



Responsibilities

• This position will provide support to various aspects of Sterilization validation, Equipment validation, facility validation and Shipping validation.

• Foster a Quality and Compliance culture for the validation program

• Support the validation program and procedural changes that enhance safety, compliance, and overall operational efficiency.

• Continuously evaluate and identify opportunities for improvement in existing validation programs and procedures.

• Support on site governance team that oversee or impact validation program and procedures.

• Accountable for the quality and robustness of validation program and procedure design.

• Represent validation program during audits and inspections



Qualifications

The position requires BS engineering or science with 8+ years of experience in the area of validation activities supporting manufacturing and development operating in regulated environment. Candidate is required to be experienced with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15)

Experience also required in in problem solving, negotiations, project management/support in a matrixed reporting environment. Six Sigma certification or background is ideal.



**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:**



+ **Last Date to Apply for Job: September 13, 2017**

+ **Grade: 10**



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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



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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