# Quality Assurance and Control

**Company**: Pfizer
**Location**: Rochester, Michigan
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: $82,700.00 to $137,900.00
**Category**: Other
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Michigan---Rochester/Senior-Validation-Engineer_4965652-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ead8fbe3-f7f

## Description

At Pfizer, you will evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements.

Responsibilities:

- Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.

- Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.

- Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.

- Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.

- Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.

- Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.

- Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.

- Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Requirements:

- High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience

- Proven expertise in Good Manufacturing Practices

- Strong working knowledge of various quality systems and processes

- Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System

- Excellent verbal and written communication skills

- Ability to work independently and in a team environment

Preferred Qualifications:

- Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems

- Experience with sterile products and medical devices

- Strong analytical and problem-solving skills

- Strong organizational and time management skills

- Ability to mentor and guide other colleagues

- Experience in regulatory audits and compliance

- Experience using common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving and enhance productivity.

Additional Information:

- Working hours: 7 am - 3:30 pm

- Annual base salary: $82,700.00 to $137,900.00

- Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary

- Comprehensive benefits and programs, including 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits

## Skills

### Required
- Good Manufacturing Practices
- quality systems
- Global Document Management System
- System Application & Products
- Quality Tracking System
- verbal and written communication

### Nice to have
- validation/qualification of pharmaceutical processes
- sterile products
- medical devices
- analytical and problem-solving skills
- organizational and time management skills
- regulatory audits and compliance
- AI tools

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Michigan---Rochester/Senior-Validation-Engineer_4965652-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)