Sr. Scientist Computer Systems Validation - Andover, MA | Biospace
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Sr. Scientist Computer Systems Validation

Pfizer Inc.

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Location:
Andover, MA
Posted Date:
7/21/2017
Position Type:
Full time
Job Code:
1051913
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job 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.

Leading the validation of compliance risk computerized local laboratory and global LIMS systems aligning with IT strategies deployed in the ADME 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.* Accountable/Responsible for leading the validation of computerized laboratory systems used in regulatory ADME laboratories 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.
* 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 colleagues locally*

Requirements

* BS/MS in Computer Science, Engineering, or scientific related discipline (Chemistry, Biology, etc.) required.
* Expert knowledge of and 8+ years' experience with regulatory agency regulations such as GLPs and predicate rule, 21 CFR Part 11, GCPs, and FDA & EMEA guidance documents required.
* 5+ 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 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 ADME/DMPK disciplines.
* Good knowledge and understanding of DMPK 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)

PHYSICAL/MENTAL REQUIREMENTS

Ability to operate in standard office and laboratory environments.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional (<5%) travel to other Pfizer research sites. Infrequent evening / weekend hours to perform hour system upgrades/ testing outside of normal working hours.

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:

  • Grade:09
  • Additional Location Information: Andover, MA
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus