Process Expert Deviation Investigator
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.
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.
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.
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.
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.
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.