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Sr Tech Sci II

Pfizer


Location:
Andover, MA
Date:
01/23/2018
2018-01-232018-02-23
Pfizer
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Job Details

**Manager, Cleaning Chemistry Validation and Manufacturing Support**







All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.







**Role Description:**







This is a team leader role responsible for major aspects of the site validation program and reports directly to the leader of the site validation program. This role provides technical support and leadership in the validation area in support of Andover's mission of being the premier multi product biological manufacturing site responsible for both commercial and clinical production. Specific areas of responsibility includes cleaning chemistry, disposables technology inclusive of extractable and leachables assessments, solution expiry and process improvements within a cGMP biopharmaceutical manufacturing facility. This is a highly visible role and provides overall leadership in the area of cleaning chemistry not only to the Andover site but the entire biological manufacturing network within Pfizer.







**Responsibilities:**







Candidate will work to develop, implement and monitor the strategy and philosophy in the area of cleaning chemistry, solution expiry and assessment of disposable components in the manufacturing process, including extractable/leachable program. Candidate will support the entire validation life cycle for biopharmaceutical manufacturing equipment in the realm of cleaning chemistry, disposables, solution expiry and process improvements. Candidate will drive the strategy for the site as well as plan and prioritize required work to be completed. Responsibilities include designing study plans and protocols in accordance with defined proprietary site strategies and applicable cGMP standards and expectations in the area of cleaning chemistry in a multi product facility. The position requires the management of full time and contracted personnel. The position requires investigation and process/component improvement project support, and continuous improvement support. Interaction with regulatory authorities during site inspections is a key aspect of this role.







**Organizational Relationships**







This position will regularly interact with Operations, Quality Assurance, Engineering Validation and Maintenance, Quality Control, Site Technical Services, Liquid Dose Manufacturing as well as others as applicable.







**Qualifications:**







Candidate must have a BS/MS in engineering, biology, or related sciences (M.S. +11yrs or BS +13yrs experience).







**Technical Skills:**







Candidate must have experience working in a biopharmaceutical or pharmaceutical manufacturing facility and have well developed hands on laboratory skills. Candidate should have an understanding of cGMP systems and practices. Candidate must be able to work across functional areas such as operations, engineering, validation, maintenance, quality and regulatory. Good communication skills, verbal and written, are required. Strong technical writing skills and experience in experimental design. Recent experience in the use of laboratory instrumentation and equipment, such as: gel electrophoresis; spectrophotometer, laboratory pipettors; conductivity & pH instruments, etc. Experience with standard desk top software (i. e. Word & Excel). Experience with laboratory scale cleaning evaluations. Experience with full scale cleaning equipment (COP washers, Cleaning skids, etc).







**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.







**Other Job Details:**







+ **Last Date to Apply for Job: 1/26/2018**







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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