Process Expert

We’re looking for a Process Expert to join our team in Indianapolis. In this role, you'll be the Subject Matter Expert (SME) for all things product and process-related, guiding our production teams toward flawless execution while ensuring compliance with GMP and quality standards. Think of yourself as the process detective – you’ll uncover the root cause of deviations, implement corrective actions, and keep our processes running like well-oiled machines. What You’ll Be Doing: Master of Documentation: Maintain and manage key manufacturing documents such as Master Batch Records, SOPs, risk assessments, and other critical paperwork. Your technical writing skills will shine as you craft and review essential documents. Investigator Extraordinaire: Own the investigations into process deviations, whether related to material transfer, API synthesis, or drug substance formulation. You’ll dig into the data, find the root cause, and ensure corrective and preventive actions (CAPAs) are put in place. Data Guru: Collect and track data for ongoing process verification (OPV) to evaluate product performance, ensuring every batch is safe and meets quality standards. Process Optimization: Support the optimization of existing processes and introduce new technologies to keep us ahead of the curve. You’ll play a key role in productivity improvements and process validation. Training Maestro: Share your knowledge with the team through training sessions and guidance. You’ll provide the support needed to keep everything running smoothly on the shop floor. Compliance Champion: Ensure processes are always "inspection-ready" and that all manufacturing practices adhere to the highest standards of GMP and regulatory requirements. Role Requirements: Education: Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent relevant experience. Experience: 3+ years in a process support role in GMP manufacturing and/or QA/QC. Expertise: Solid understanding of pharmaceutical processes, GMP, and regulatory compliance. Previous experience with compliance investigations is a must. Skills: Exceptional technical writing skills – think white papers, SOPs, and reports that make people say "Wow!" Desirable (but not required) Skills: Radio Pharma Experience: If you’ve worked in radiopharmaceuticals, we’d love to hear from you. Leadership Experience: If you’ve managed teams or collaborated cross-functionally, that’s a plus! Pay & Schedule: Pay Range: $30 - $40 per hour, depending on skills and qualifications. Schedule: Monday to Friday, 8am - 5pm. Location: Onsite in Indianapolis, IN 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