Senior Validation Specialist 1

Use Your Power for Purpose
The Senior Validation Specialist 1 will support a diverse variety of qualification activities for manufacturing processes and equipment within a biopharmaceutical manufacturing facility, including shipping validation, equipment qualification, steaming and depyrogenation qualification.
What You Will Achieve
This role will also provide technical support for continuous improvement projects, driving the projects to completion to support the ongoing activities within a manufacturing environment.
As a Senior Validation Specialist 1, you will act as a subject matter expert / program owner within the team, ensuring that the program remains compliant with corporate, regulatory, and industry standards and regulations. The incumbent will develop strategies and updates to program documentation to resolve complex challenges to improve the validation program at the site level. The incumbent in this position will provide guidance for the execution of validation activities, collaborating with the SME's of the site Quality Assurance Validation group, resolving deviations to resolve complex deviations and identify appropriate strategies for validation activities.
The incumbent will exercise own expertise to work independently with instruction on complex problems.
How You Will Achieve It
The Senior Validation Specialist 1 is expected to utilize their own subject matter expertise, as well as collaborate with other site validation SMEs, to define, standardize and support the Steaming, Equipment, and Shipping validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.
The incumbent's responsibilities will include, but are not limited to, the following:

• Providing support for the validation program and validation projects at the Pfizer Andover site
• Applying comprehensive technical knowledge and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs, utilizing industry knowledge to drive programmatic updates to maintain compliance
• Authoring, reviewing, and approving routine to highly complex validation deliverables [Validation Plan, Validation Strategy, Requirements Specification, Qualification Protocols (IQ,OQ, PQ), Change Control Implementation Plans and Impact/Risk Assessment, deviations, investigations, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact], for appropriateness, completeness and alignment with quality, validation and regulatory expectation, providing sounds quality and compliance judgment to ensure meeting Pfizer Quality Standards, 21CFRpart11, ICH, MHRA, WHO guidance
• Supporting internal and external audits
• Providing technical support and fully implement change controls and commitments, including regulatory commitments and change controls with regulatory impact

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Experience with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and/or Medical Device Validation requirements (CFR 811)
• Comprehensive understanding of equipment/steaming/shipping validation experience required
• Strong knowledge of other validation disciplines, GMP and regulatory requirements, and data integrity principles
• Demonstrated leadership, management, and technical capabilities
• Proven project management, analytical, and problem-solving skills
• Effective writing and oral communication skills and fluency in English

PHYSICAL/MENTAL REQUIREMENTS
Normal sitting, standing and walking requirements to facilities and in a laboratory environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some off hour support may be required to support staff and operations.
Other Job Details:

• Work Location Assignment: On Premise
• Last day to apply: February 2nd

The annual base salary for this position ranges from $99 200,00 to $160 500,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12,5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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. This position requires permanent work authorization in the United States.
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Engineering