Associate Process Expert (2nd shift/Wed-Sat)
About The Position
Are you motivated by solving complex manufacturing challenges where quality, compliance, and patients come first? As an Associate Process Expert, you will play a critical role on the shopfloor, acting as a trusted partner to manufacturing and quality teams to resolve unexpected events and ensure processes remain compliant, robust, and inspection‑ready. Your work will directly support safe, reliable production of our cutting-edge Radioligand Therapy (RLT) treatments by leading investigations, driving effective corrective and preventive actions, and strengthening a culture of continuous improvement in a fast‑paced Good Manufacturing Practice (GMP) environment.
Requirements
- Bachelor of Science degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific discipline.
- Minimum one year of experience in a process support role on the shopfloor of Good Manufacturing Practice manufacturing and/or Quality Assurance or Quality Control.
- Proven understanding of pharmaceutical manufacturing processes and regulatory requirements.
- Strong technical writing skills with the ability to produce clear, complete, and inspection‑ready documentation.
- Demonstrated quality mindset with the ability to work effectively on the shopfloor with cross‑functional teams.
Nice To Haves
- Hands‑on experience authoring and managing deviations, investigations, and corrective and preventive actions.
Responsibilities
- Provide on‑the‑floor support by triaging unexpected manufacturing events with Production and Quality teams.
- Open, author, and drive deviations and investigations to timely, compliant closure.
- Apply process knowledge and root cause analysis tools to identify and resolve product or process issues.
- Develop, document, and implement effective corrective and preventive actions to prevent recurrence.
- Ensure investigations are complete, accurate, defensible, and inspection‑ready for critical and major events.
- Execute or support experimental plans and manufacturing runs required to support investigations.
- Partner cross‑functionally to maintain compliant manufacturing operations during and after deviations.
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- vacation, personal days, holidays and other leaves
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
