Engineering Validation Associate
Engineering Validation Associate
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Job Description
Use Your Power for Purpose
Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible innovative and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development maintenance compliance or analysis through research programs your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
What You Will Achieve
In this role you will:
- Evaluate review and approve validation master plans protocols and reports ensuring compliance with regulatory requirements and company policies.
- Troubleshoot validation problems for equipment and performance processes conducting statistical analysis of testing results to address process anomalies.
- Write review and approve validation process documents and technical reports related to equipment products and processes.
- Contribute to project tasks and milestones organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.
- Make decisions within limited options to resolve basic problems working under the supervisors direction and seeking guidance from colleagues.
- Ensure work is regularly reviewed for technical judgment completeness and accuracy exercising judgment with reliance on the supervisor.
- Determine the process capability of new equipment through the execution of approved protocols incorporating defined parameters into operating procedures and batch records.
- Assist with the development of validation protocols manage regulatory queries and responses and participate in deviation investigations to identify root causes and define corrective and preventative actions.
- Adhere to all company and Good Manufacturing Practices (cGMP) procedures safety regulations and participate in the development of validation programs to stay current with cGMPs and industry standards.
- Work effectively as a member of the Quality Operations (QO) cGMP training team collaborating with Business Area Training Leads Coordinators and SMEs to support cGMP and site training initiatives reporting to the Validation Section Manager and summarizing data into concise reports for review and approval.
Here Is What You Need (Minimum Requirements)
- Applicant must have a bachelors degree with any years of experience or an Associates degree with 4 years of relevant experience or a high school diploma (or equivalent) and 6 years of relevant experience
- Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices
- Strong organizational skills and the ability to manage changing deadlines
- Proficiency in Microsoft Office particularly Excel for data evaluation
- Strong written and verbal communication skills
- Ability to work in a team environment and collaborate effectively with colleagues
- Basic understanding of validation principles and practices
Bonus Points If You Have (Preferred Requirements)
- Technical writing experience particularly within the pharmaceutical industry
- Laboratory process validation expertise
- Working knowledge of equipment qualification and calibration especially for laboratory equipment
- Experience with regulatory queries and responses
- Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams
- Adaptability and flexibility in a dynamic work environment
- Commitment to continuous learning and professional development
PHYSICAL/MENTAL REQUIREMENTS
- Ability to enter and navigate cleanroom type environments in manufacturing facilities.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
- Schedule is primarily day shift but at times it will be necessary to work additional times to support emergency manufacturing needs (either onsite or remote)
- Work Location Assignment:On Premise colleagues work in a Pfizer site because its needed to get their job done. They may have flexibility to work remotely from time to time but they are primarily on-site.
Other Details:
- Last day to apply: August 18 2025.
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 providers 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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
IC
Employment Type
Full-Time
