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: Jan 20th
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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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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