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Pfizer · 1 month ago

Engineering Validation Associate

United States - North Carolina - Sanford

Full-time

Onsite

New Grad, Entry Level

$66K/yr - $111K/yr

0+ years exp

Pfizer is committed to delivering safe and effective products to patients, and they are seeking an Engineering Validation Associate. In this role, you will evaluate and approve validation plans and reports, troubleshoot validation problems, and ensure compliance with regulatory requirements.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

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 supervisor's 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 Engineering Validation 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

Qualification

FDA RegulationsManufacturing PracticesValidation PrinciplesMicrosoft ExcelLaboratory Process ValidationTechnical WritingOrganizational SkillsCommunication SkillsTeam CollaborationAdaptability

Required

Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of 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