Associate Validation Area Specialist Jobs

General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred

With P&O review/agreement, equivalent combination of education and internal NN business/operational experience may be substituted for degree as appropriate

Keeps track & informs management about fluctuation in workload

Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave

Follow all safety & environmental requirements in the performance of duties

Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the pharmaceutical or medical device industry

· Knowledge in working with current issue and effect management software

· Knowledge of risk/hazard analysis of business requirements leveraging GAMP 5

· Develops manual test cases with associated test runs using requirement and functional specification documents

· Knowledge of performing validation of BECS Software and Standard Operating Procedures

· Knowledge of FDA and international medical device regulations

· Prefer knowledge and understanding of applicable Regulated Software Application (RSA) modules

Demonstrates strong client service skills, teamwork, and collaboration.

Strong computer, scientific, and organizational skills

A combination of college and related technical experience will be considered (e.g., 14+ years’ experience)

Three years of regulatory experience including quality system/program development

Validation Specialist responsibilities include, but are not limited to, the following

Benefits & Perks To Foster Work/Life Balance

Strong understanding and experience with Aseptic techniques, cell manufacture processes and technologies preferred

Review of Validation protocol related data evidence

Review of CSV related data evidence

Review of QC related data evidence

Review of Tech Transfer related data evidence

Compile, analyze qualification/validation data, and develop Trace Matrices (TM).

Manage multiple projects, ensuring effective customer communication.

Demonstrate excellent written, verbal, and presentation skills.

Assess project scope, manage change, and solve problems.

Bachelor’s degree in a scientific, technical, or engineering discipline with 5 to 7 years of experience working within an FDA-regulated environment.

Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing Practices (GAMP).

Experience in project management, test design, process flow, and troubleshooting.

5+ years relevant experience in validation and GMP.

Proficiency in manage multiple projects, setting priorities, and working in a fast-paced environment.

Experience using precision measuring instrument and electronic testing devices.

Excellent oral and written communication skills

Excellent organizational and interpersonal skills

Provide QA support to the Electronic Asset Management System (EAMS) including work order review and approval, as needed.

May participate in quality risk management activities.

Ability to present to peers/management locally and virtually inclusive of communicating with other Pfizer Sites.

Contributes to PSOQ management team initiatives and objectives.

The successful candidate will possess strong interpersonal, teamwork, and collaboration skills.

2+ years of relevant experience within a GMP environment required.