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

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your
problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

How You Will Achieve It

• Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Executes validation studies to include protocol preparation, scheduling, protocol execution, analyzation of data and final report generation.
• Participates in presentation of results to Regulatory Agencies when necessary.
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Participate and/or lead discussions with internal, customer and regulatory agencies
• Prepare responses to internal, customer and regulatory agency audits
• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
• Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• May supervise and/or mentor junior level engineers.

Qualifications

Must-Have

• Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience;
• OR an Associate's degree with six years of experience;
• OR a Bachelor’s degree with at least three years of experience;
• OR a Master’s degree with more than one year of experience.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
• Must be able to interact with varying levels within the company
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
• Strong conflict resolution skills
• Must be able to work multiple shifts as needed to meet deadlines

Nice-to-Have

• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems , as related to sterile products and medical devices
• Experience in a leadership position/coaching position

PHYSICAL/MENTAL REQUIREMENTS

Must be able to lift and carry light loads as necessary in conducting testing. May involve standing for long periods of time. Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements. Ability to multi-task and keep several activities and projects moving forward in order to meet defined timelines is a must.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Primary work schedule is Day shift, Monday – Friday but evenings, weekends and holiday work will be required, as needed. Some travel, < 10% may be periodically required.

Relocation support available: Yes
Work Location Assignment: On Premise

Last date to apply: 2/7/2023

Relocation assistance may be available based on business needs and/or eligibility.

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.

Quality Assurance and Control