Senior Process Validation Analyst – Parenteral Manufacturing

PVH (Tommy Hilfiger/Calvin Klein); Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

Supplemental Life Insurance

Spouse Life Insurance

Child Life Insurance

401(k) Retirement Savings Plan with 公司

Job summary

Simtra BioPharma Solutions in Bloomington, IN, seeks a Process Validation Analyst to execute validation activities meeting global regulatory requirements and company standards. You’ll work with clients and cross‑functional teams to develop validation strategies, protocols, and summary documentation.

This role emphasizes risk assessment, CPV, audits, and ongoing optimization of processes to ensure product quality and patient safety.

Qualifications

• Bachelor’s degree in science or engineering field.
• Minimum five years of technical experience in parenteral manufacturing, with validation preferred.
• Strong communication and ability to work independently or in teams.

Responsibilities

• Support and maintain the process validation program.
• Develop, revise, and maintain procedures, protocols, and summary reports.
• Partner with clients and internal teams to define validation scope, requirements, and objectives.
• Design, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.
• Perform risk assessments to support validation activities.
• Plan, coordinate, and execute validation activities for new and existing products.
• Analyze validation data and prepare documentation to support conclusions.
• Conduct annual reviews and Continued Process Verification (CPV) activities.
• Lead or support investigations related to validation, including NCRs and CAPAs.
• Monitor regulatory requirements and industry best practices.
• Create and maintain visual management tools and controls for the Process Validation group.
• Serve as a subject‑matter expert during regulatory, client, and internal audits.
• Develop industry expertise and project proficiency while working independently.
• Identify and implement opportunities to optimize processes and improve operational efficiency.

Skills

Process validation

Statistical analysis

Regulatory compliance

Documentation

Cross‑functional collaboration

Education

Bachelor’s degree in science or engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPLM

Pilgrim

TrackWise

Job description

Simtra BioPharma Solutions in Bloomington, IN, seeks a Process Validation Analyst to execute validation activities meeting global regulatory requirements and company standards. You’ll work with clients and cross‑functional teams to develop validation strategies, protocols, and summary documentation.

This role emphasizes risk assessment, CPV, audits, and ongoing optimization of processes to ensure product quality and patient safety.