Process Expert Deviation Investigator

Description:

Now Hiring: Process Expert Deviation Investigator | Onsite in Indianapolis
Pay: $30 – $40/hour (based on skills and qualifications) | Monday–Friday, 8:00 AM – 5:00 PM

PDS Tech Commercial, in partnership with a global leader in pharmaceutical manufacturing, is seeking a Process Expert Deviation Investigator to join their team in Indianapolis. This critical role ensures manufacturing processes consistently deliver safe, high-quality products by driving investigations, supporting compliance, and optimizing operations.

If you’re motivated to solve complex problems and make a real impact in pharmaceutical manufacturing, this is your opportunity.

What You’ll Do

As a Process Expert, you’ll act as the subject matter expert for product and process knowledge—serving as the first line of support for production teams. In this role, you will:

  • Lead deviation investigations: Identify true root causes and drive corrective and preventive actions (CAPAs) across manufacturing operations.

  • Ensure documentation accuracy: Manage Master Batch Records, SOPs, risk assessments, protocols, and related documentation.

  • Support technical writing: Write and review SOPs, batch records, white papers, and investigation reports.

  • Track performance: Collect data for ongoing process verification (OPV) and evaluate product performance to drive improvements.

  • Drive compliance: Ensure processes are always inspection-ready and aligned with GMP and regulatory standards.

  • Optimize processes: Support process validation, continuous improvement projects, and the introduction of new technologies.

  • Guide teams: Provide training, share knowledge, and demonstrate leadership to help the production team succeed.

What You Bring

  • Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent experience.

  • 3+ years of experience in GMP manufacturing and/or QA/QC within a process support or shop floor role.

  • Strong understanding of pharmaceutical processes, GMP requirements, and regulatory standards.

  • Experience leading compliance investigations with proven technical writing skills.

Preferred:

  • Radiopharmaceutical experience.

  • Leadership and cross-functional collaboration experience.

Why Join Us

At PDS Tech Commercial, you’ll work with a global pharmaceutical leader committed to advancing healthcare and patient well-being worldwide. This role gives you the chance to:

  • Take ownership of critical deviation investigations that directly impact product safety and compliance.

  • Gain exposure to innovative processes and cutting-edge pharmaceutical technologies.

  • Develop leadership skills while collaborating with cross-functional experts.

  • Contribute to meaningful work that ensures life-saving medicines reach patients safely and reliably.

Ready to Lead Investigations That Make a Difference?

If you thrive on problem-solving, compliance, and driving process excellence, we want to hear from you. Apply today and take your next career step with PDS Tech Commercial.


This position requires use of information or access to facilities subject to the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR). These regulations may limit access of controlled technologies: 1) to U.S. Persons, including U.S. Citizens, lawful permanent residents, and other narrow categories including refugees and asylees, or 2) to certain foreign nationals that have received an export license.                   



Pay Details: $30.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance


Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.



 
Job Number: US_EN_33_022202_2456886
Job Location: Indianapolis, IN
Rate: 30-40
Per Diem: --
Overtime: --
Duration: indef
Start Date: ASAP
Input Date: 09/25/2025
Firm Name: PDS TECH COMMERCIAL, INC
Attention:
Address: 545 E JOHN CARPENTER FWY STE 950
City, State: IRVING, TX 75062
Phone: 214/647-9600
800 Phone: 800/270-4737
Email: Client.Services@pdstech.com
Website: Go To PDS Tech Commercial Website
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