Senior Specialist, Engineering
At a glance
AI generatedTL;DR
The Senior Specialist, Engineering role at West Point Lyophilization Technical Operations involves providing technical guidance and support for the Live Virus Vaccines manufacturing process. This individual contributor will lead or work on teams to implement continuous improvement projects, manage change control documentation, and conduct investigations to ensure compliance and operational excellence. Key responsibilities include authoring complex technical documents, conducting experimental protocols, and collaborating with cross-functional teams to resolve issues related to safety, compliance, automation, and equipment. The ideal candidate has a B.S. or higher in Engineering or a relevant field, along with 6+ years of experience in GMP environments, particularly in vaccine manufacturing. Proficiency in Data Analytic Tools like Spotfire and Power BI is essential, as well as familiarity with MES systems and Quality Risk Assessment methodologies. This role demands expertise in deviation management, process optimization, and regulatory compliance to support the company’s mission in producing high-quality vaccines efficiently.
Skills
What you'll do
- Provide technical support for lyophilization manufacturing and lead continuous improvement projects.
- Author or approve complex Change Control documentation to ensure timely project implementation.
- Conduct experimental protocols using lab facilities and production equipment for process validation.
- Monitor process health through Continuous Process Verification (CPV) activities and annual reviews.
- Prepare regulatory submission documentation and participate in facility inspections.
- Investigate deviations, determine root causes, and implement corrective actions to prevent recurrence.
- Lead projects aimed at improving Right-First-Time performance and reducing processing cycle times.
What we're looking for
- B.S. or higher in Engineering, Biomedical Sciences, or related field.
- Minimum 6 years of GMP experience in Operations, Technical Operations, etc.
- Experience with deviation management and change control processes.
- Proven ability to author technical documentation in a cGMP context.
- Expertise in lyophilization of biologics/vaccines within sterile manufacturing facilities.
- Knowledge of Manufacturing Execution Systems (MES) and Data Analytic Tools.
- Strong leadership, communication, and teamwork skills.
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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