Process Validation Associate III

Simtra US LLC; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Co

Paid Holidays

Paid Time Off

Paid Parental Leave

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra US LLC is seeking a Process Validation professional in Indiana to execute validation activities for parenteral products. You will develop protocols, analyze data, and ensure compliance with global regulations. You will interact with cross‑functional teams and clients and report to the Process Validation Sr.

Manager. You should have at least 5 years in process validation, strong statistics skills, and experience with GMP environments.

Qualifications

• Bachelor’s degree in science or engineering is required.
• Minimum 5 years of technical experience in process validation, preferred in parenteral manufacturing.
• Proficiency with Microsoft Word, Excel, Outlook and enterprise software tools.
• Ability to communicate effectively at all levels and work independently.
• Strong knowledge of validation practices, risk assessment, and continuous improvement.

Responsibilities

• Support and maintain the process validation program.
• Develop and maintain validation procedures, protocols, and summary reports.
• Collaborate with clients and internal teams to define scope and objectives.
• Design, execute, and analyze studies to establish process parameters.
• Lead investigations related to NCRs and CAPAs and monitor regulatory requirements.

Skills

Process validation expertise

Regulatory compliance

Data analysis

Communication skills

Independent work

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Tools

JDE

BPLM

Pilgrim

TrackWise

Job description

The role:

This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross‑functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Process Validation Sr. Manager.

Responsibilities

• Support and maintain the process validation program.
• Develop, revise, and maintain process validation 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 process validation activities.
• Plan, coordinate, and execute process validation activities for new and existing products.
• Analyze validation data and prepare documentation to support validation conclusions.
• Conduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.
• Lead or support investigations related to validation activities, including Non‑Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
• Monitor regulatory requirements and industry best practices to ensure compliance and continuous improvement.
• Create and maintain visual management tools and controls for the Process Validation group.
• Serve as a Subject Matter Expert (SME) for process validation during regulatory, client, and internal audits.
• Develop industry expertise and project proficiency while working independently on assigned initiatives.
• Identify and implement opportunities to optimize departmental processes and improve operational efficiency.

Required Qualifications

• Bachelor’s degree required, preferably in a science or engineering‑related field.
• Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
• Ability to communicate effectively at all levels.
• Sound industry knowledge, project proficiency, and the ability to work independently. May be considered a subject matter expert (SME) in various disciplines.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.

Physical / Safety Requirements

• Duties may require overtime work, including nights and weekends
• Must be able to gown for Grade C environments
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time.

Benefits

• 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 Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
  • Short and Long‑Term Disability Insurance
• Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.