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Principle Scientist, Validation and Systems

Pfizer


Location:
Groton, CT
Date:
08/18/2017
2017-08-182017-09-16
Job Code:
1609654
Pfizer
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Job Details

Job Title Principle Scientist, Validation and Systems

JobID 1609654

Location: Groton, CT

Description Validation and Systems Administration Lead



**ROLE SUMMARY**

Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region). Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.

Leading the validation of compliance risk computerized local laboratory and global LIMS systems aligning with IT strategies deployed in the CBRT and Genomics laboratories including:



+ Creation of system requirements, specifications, and trace matrices, data flow mappings from acquisition to reporting

+ Authoring computer validation plans, test scripts, SOPS, and reports.

+ Directing the execution and review of validation test scripts.

+ Software validation project manager coordinating and maintaining project plan, resources, timelines, and milestone delivery.



+ Provide scientific computer system application support and administration in accordance with applicable regulations and SOPs



**ROLE RESPONSIBILITIES**

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.



+ Accountable/Responsible for leading the validation of computerized laboratory systems used in regulatory Early Clinical Development laboratories (CBRT and Genomics labs) leading the following aspects of regulatory systems validations:

+ Validation project manager coordinating and maintaining project plan, resources, timelines, and milestone delivery.

+ Creation of system requirements, specifications, and trace matrices, data flow mappings from acquisition to reporting

+ Authoring computer validation plans, test scripts, SOPS, and reports.

+ Directing the execution and review of validation test scripts.

+ Leading the review of Compliance System SOPs & periodic reviews.

+ Work with external instrument/software vendors to drive additional validations as required

+ Maintaining a validation roadmap for compliance systems including active validations, upcoming validation requests, periodic reviews, SOPs, and planned audit activities.

+ Performing business analysis and regulatory assessments of new informatics systems being requested for use supporting regulated studies.

+ Contributing to a variety of informatics projects to improve productivity and efficiency and further the success of the business.

+ Engage in a dialogue with key colleagues and stakeholders, identify opportunities; business and user needs and translate them in specific actions, and projects.

+ Provide computer system application support and/or business lead to designated compliance risk informatics systems.

+ Act as point of contact with QA on computer system audits/inquires.

+ Provide basic GxP and 21 CFR Part 11 training to local colleagues.



**QUALIFICATIONS**



+ BS/MS in Computer Science, Engineering, or scientific related discipline (Chemistry, Biology, etc)

+ Expert knowledge of and 10+ years' experience with regulatory agency regulations such as GLPs and predicate rule, 21 CFR Part 11, GCPs, and FDA & EMEA guidance documents.

+ 8+ years experience authoring computer system compliance risk validations, periodic reviews, and change controls in accordance with Pfizer validation SOPs, FDA GxP regulations, and 21 CFR Part 11 guidelines.

+ Successful interactions on internal corporate QA and regulatory agency computer system audits.

+ In depth knowledge of ADME/ DMPK/ and Biomarker science disciplines in the small molecule and/or large molecule modality space with experience/expertise in one or more of the IT systems used by the Clinical Biomarker or Genomics disciplines.

+ Good knowledge and understanding of Bioanalytical LIMS systems and architectures (eg Watson, Mass Spectrometers, electronic workbooks).

+ Good knowledge and understanding of Bioanalytical lab instrumentation use within a regulated lab environment (Mass Spectrometers, Flow Cytometers, ELISA, LBA, Genomics Platforms)



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 15, 2017**

+ **Grade: 011**

+ Eligible for Relocation Package: yes

+ Eligible for Employee Referral Bonus: yes



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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