Process Validation Associate III

Simtrabps

Bloomington (IN)

On-site

USD 90,000 - 130,000

Full time

14 days+

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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 (Simtra) is a world‑class Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington, Indiana, and Halle/Westfalen, Germany, we deliver pre‑filled syringes, liquid and lyophilized vials, diluents, powders, and vaccines for direct patient injection worldwide.

Overview

Our product portfolio spans biologics, small molecules, cytotoxics, highly potent compounds, and vaccines. Focused on quality, continuous improvement, and high regulatory standards, we provide cGMP manufacturing along with formulation, lyophilization optimization, global regulatory support, and secondary packaging. Our teams help clients scale, innovate, and bring life‑changing medicines to patients worldwide.

Why Join Team Simtra

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding expectations.
Make it TOGETHER – We work as one, respecting each voice and leveraging unique strengths across teams.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling commitments to customers, patients, and team members.
Make it COUNT – We take pride in our day‑to‑day work, knowing the impact we make and continuously improving patient health.

Role Summary

The Process Validation Analyst executes process validation activities that meet worldwide regulatory agency requirements, internal company standards, and current industry practices. This role reports to the Process Validation Sr. Manager and works closely with clients and cross‑functional teams to develop validation strategies, protocols, and summary documentation.

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.

Qualifications

Bachelor’s degree in a science or engineering‑related field.
Minimum five years of technical experience in parenteral manufacturing, with validation preferred.
Computer proficiency in Microsoft Word, Excel, Outlook, and enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise).
Strong communication skills at all levels.
Sound industry knowledge and project proficiency; potential to become an SME.
Ability to identify and implement process optimizations.
Capability to work independently or in teams.

Physical / Safety Requirements

May require overtime, nights, and weekends.
Must be able to gown for Grade C environments.
Use of hands and fingers to manipulate office equipment.
Position requires sitting for long periods, with occasional walking or standing.

Day One Benefits