Validation Lead/Associate III, Commissioning Qualification, Validation

Simtrabps; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Flexible Spending Accounts

Paid Time Off

Education Assistance Program

Employee Ownership Plan

Onsite Workout Facility

Onsite Cafeteria

Job summary

Simtrabps is seeking a Validation Lead/Associate III based in Bloomington, Indiana. The successful candidate will oversee and execute equipment FAT, SAT, IQ, OQ, and PQ activities within the Validation and Qualification Department. This role provides guidance and leadership, contributes to Sterility Assurance, and ensures compliance with documentation activities.

The position requires a Bachelor’s degree in a relevant science or technical field and at least two years of related experience, including supervisory roles. Benefits include medical and dental coverage, 401(k) with company match, and flexible spending accounts.

Qualifications

• Bachelor’s degree required, preferably in a science or technical area.
• Minimum of 2 years related experience required, preferably 2 years supervisory experience.
• Ability to meet Grade C and D gowning requirements.

Responsibilities

• Provide guidance, support, direction, and leadership through positive interaction.
• Develops procedures and supports the facility equipment qualification and validation program.
• Leads and participates in planned maintenance activities.

Skills

Critical thinking

Creative thinking

Problem solving skills

Computer proficiency in Microsoft Word

Computer proficiency in Excel

Computer proficiency in Outlook

Education

Bachelor’s degree in a science or technical area

Tools

Microsoft Word

Excel

Outlook

Enterprise software (JDE, BPLM, Pilgrim, Trackwise)

Job description

This role:

The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual contributor within the Validation and Qualification Department. This position oversees and executes equipment FAT, SAT, IQ, OQ, PQ activities along with validation and documentation activities. In addition, it includes contribution roles within Sterility Assurance and Cleaning Validation. This position reports to the Sr. Manager, Technical Services.

Responsibilities:

• Provide guidance, support, direction, and leadership through positive interaction with all personnel during daily operations.
• Represents CQV in internal, client, and regulatory audits as needed.
• Develops procedures and supports the facility equipment qualification and validation program.
• Conducts or coordinates performance qualification execution for new products.
• Maintain and generate accurate and complete records, reports and documentation as required for summary preparation.
• Makes process improvements and modifications to the validation program as needed.
• Initiates and drives change controls (CCM).
• Review and approve Master Batch Records, Master Specification Sheets, Line Manufacturing Records and Bill of Materials.
• Author and approve qualification and validation documents.
• Attend Equipment FAT, including international travel as required.
• Leads and participates in planned maintenance activities, including HEPA certification and visual airflow testing (smoke testing).

Requirements (Education and Experience):

• Bachelor’s degree required, preferably in a science or technical area.
• Minimum of 2 years related experience required, preferably 2 years supervisory experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
• Self‑directed with high initiative and ownership.
• Critical thinking, creative thinking, and problem solving skills.

Physical / Safety Requirements:

• Ability to meet Grade C and D gowning requirements.
• Duties will require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate equipment is required.
• Position requires standing for long hours, but may involve walking or sitting for periods of time.

Benefits:

• Day One 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

Current benefit offerings are in effect through 12/31/26.

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.

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