Associate Validation Engineer

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. You will support in the writing, review and approval of validation process documents and technical reports related to equipment, products and processes.

As an Associate Validation Engineer, you will be responsible for validating/qualifying the systems used to manufacture drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products. The area of responsibility will be the Equipment/Facility/Utility Qualifications (IQ, OQ, PQ) and requalification's in the Sterilization, Formulation and Commodity Preparation business unit areas. You will utilize your knowledge and commitment to 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

• Executes equipment validation studies to include protocol preparation, scheduling, execution, data analyze data and generation of summary reports reviewed and approved by validation, production and quality management.
• Assists with development of validation protocols and participate in presentation of results to Regulatory Agency, when necessary.
• Participates in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Adhere to all company and Good Manufacturing Practices procedures, along with safety regulations within the plant and participate in development of validation programs as needed to remain current with cGMP, Industry and Regulatory Requirements.
• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
• Works in a team environment to meet all team objectives and communicate progress on scheduled projects.

Qualifications

Must-Have

• Applicant must have High School Diploma (or Equivalent) with  six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience. 
• Background in mechanical, electrical, chemical or biomedical engineering either academic or industry.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance or Good Manufacturing Practices is required.
• Technical knowledge and experience with validation / qualification processes.
• Excellent organizational skills, and ability to handle changing deadlines.
• Strong communication with written and verbal skills.
• Working knowledge of Microsoft Office, especially Excel for evaluation of data.
• 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.
• Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.

Nice-to-Have

• 2 years + of experience in the pharmaceutical industry.
• Experience working with periodic performance qualifications (PPQ), Kaye Validator, Washer, wet loads, equipment loads, and / or sterilizer.

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.
• Technical writing experience
• Working knowledge of equipment qualification and calibration instrumentation.

 
Work Location Assignment: On Premise

Last Date to Apply to Job: June 8, 2023

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.

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