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 Validation team. You will be responsible for the creation, review and approval of validation master plan, SOPs, 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 validation process documents and technical reports related to equipment, facilities, utilities, computer systems, products and processes.

As an Associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

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

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Determine process capability of new equipment through execution of approved protocols and assure defined parameters are incorporated into respective operating procedures and batch records.
• Assists with development of validation protocols and manage Regulatory queries and responses.
• Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Adhere to all company and Good Manufacturing Practices {also cGMP} procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.
• Ensure that equipment, facilities, computer systems, and utilities are validated in accordance with {Current} Good Manufacturing Practices {part of GxP} principles, regulatory requirements, and company policies and standards.
• Work on summarization of data into concise reports that is reviewed by the Quality Engineering team.
• Define problems, collect data, establish facts, and draw valid conclusion.
• Work in a team environment to meet all team objectives and communicate progress on scheduled projects.

Qualifications

Must-Have

• High School Diploma (or equivalent) with 6+ years of relevant experience,
• Or an Associate's degree with 4+ years of experience,
• Or a Bachelor's degree with 0+ years of experience.
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills
• Excellent attention to detail.
• 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

Nice-to-Have

• Technical writing experience
• Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices
• Working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to lift and carry light loads as necessary in conducting testing. Weekend or long hours based on testing schedule.
• able to manage multiple tasks at once.
• 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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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

Work Location Assignment: Flexible

Relocation Assistance Available: NO

Last date to apply: 3/27/2023

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

Quality Assurance and Control