Senior Specialist, Engineering
At a glance
AI generatedTL;DR
The SSO Pilot Plant within the Process Research and Development organization at Rahway, NJ, is seeking a Senior Process Engineer to join their team. This role involves supporting facility operations, process development activities, and compliance investigations while ensuring GMP documentation is up-to-date. Day-to-day responsibilities include preparing for batch processing readiness, managing equipment maintenance, training staff, and collaborating with cross-functional teams to ensure quality and safety in clinical supply manufacturing. The ideal candidate will have a background in chemical engineering or related fields, experience in small molecule drug substance development, and familiarity with GMPs and Good Documentation Practices. Strong communication skills, adaptability, and the ability to work in fast-paced environments are essential. Additionally, proficiency in automation systems like DeltaV is preferred for this role that demands technical expertise and leadership within a highly regulated pharmaceutical setting.
Skills
What you'll do
- Prepare for and support batch processing readiness and execution activities.
- Author and approve GMP documentation, including Standard Operating Guidelines and Procedures.
- Support equipment maintenance, setup, cleaning, and raw material inventory management.
- Mentor staff, provide training, and supervise GMP activities in the pilot plant.
- Conduct deviation investigations, implement corrective actions, and support compliance initiatives.
What we're looking for
- Bachelor’s degree in relevant scientific field with 4+ years of experience, or higher degrees with less experience.
- Experience with small molecule drug substance and biologics process development and scale-up.
- Familiarity with cGMPs, GDPs, and S&E regulations for pharmaceutical development.
- Operations experience in a GMP clinical supply facility or manufacturing environment.
- Ability to convert new drug substance processes into executable steps and procedures.
- Experience providing technical mentorship and supporting compliance investigations/change management.
Employer
About MSD
MSD (Merck Sharp & Dohme) is the international name for Merck & Co., a major U.S.-based pharmaceutical company.
MSD currently has 14 open roles on FindRole.
Listed pay typically runs $117,000–$184,200 across 13 roles with salary data.
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