Senior QA Validation Specialist I

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. In your role, you will join a team which is responsible for the establishing and implementation of the validation strategy for a given sector of validation (i.e. equipment, computer system validation, continued process verification, process, cleaning, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. More broadly, you will be joining a department which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Provide guidance, lead,or co-lead projects, manage own time to meet objectives.

• Forecast and plan resource requirements (people, financial and technology) for projects acrossthe division.​

• Plan and coordinate the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols and Impact / Risk Assessments.

• Review and approve change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.

• Work with Operations, Quality, Technical groups and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.

• Ensure the validated state of equipment, instruments and systems supporting manufacturing is compliant with corporate policies and regulatory requirements.

• Providetechnical support and participatein the implementation of change controls and commitment action items.

• Prepare material for and deliver validation training on validation topics,including,training on guidance/best practices, or site-specific requests for validation workshop training.

• Provide support to project teams on compliance and technical issues related to validation to ensure compliance with company policies and government regulations.

• Review and approve investigations, commitments and procedures and maintenance work orders as they relate to validation.

Qualifications

Must-Have

• Bachelor’s Degree and 10 years of experience in a GMP pharmaceutical manufacturing environment (Quality Assurance of Validation).

• Excellent communication skills and able todeliver effective presentations to a variety of audiences.

• Ability to build relationshipswith internal and external stakeholders toinfluence outcomes.

• High proficiency in Word, Excel and have demonstrated aptitude for computerized systems.

• Excellent communication skills and proven ability to collaborate across departments and organizations.

• Excellent organizational skills, ability to manage multiple priorities, projects, and day-to-day work with minimal supervision with high accuracy.

Nice-to-Have

• Master’s degree and relevant pharmaceutical experience.

• Knowledge of GMP regulations/guidance(21 CFR Parts 11, 210 & 211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.

• Background in problem solving, negotiations, data integrity principles and project management/support in a matrixed reporting environment.

• Good understanding of risk management methodologies, with a proven ability to apply to Bio-pharmaceutical operations.

PHYSICAL/MENTAL REQUIREMENTS

N/A

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

N/A

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.