Merck KGaA Darmstadt Germany - West Point, PA
posted 3 months ago
Full-time - Mid Level
Onsite - West Point, PA
1,001-5,000 employees
Chemical Manufacturing
About the position
The Senior Specialist, Engineering in Technical Operations at our vaccine manufacturing facility is responsible for supporting process transfers, qualifications, and technical initiatives to ensure high-quality vaccine production. This role involves collaboration with cross-functional teams to facilitate the start-up of a new vaccine filling and lyophilization facility, focusing on design, commissioning, and regulatory compliance.
Responsibilities
- Lead and/or work as a technical leader on process initiatives associated with product transfers and/or commercial production.
- Set and drive strategic initiatives associated with process transfers.
- Support the facilitation of tactical initiatives related to process design, engineering studies, and change control.
- Author and update technical and manufacturing documents necessary for process design and qualification.
- Develop and execute process change controls, including risk and impact assessments.
- Support process improvement projects and complex manufacturing investigations.
- Provide technical support to manufacturing for complex problems and issues.
- Support digital and data integrity initiatives for the project.
- Develop and assure consistent application of standardized work and process tools.
- Examine issues from diverse perspectives to understand and resolve root causes.
- Support regulatory submission preparation and inspections for the facility.
Requirements
- Bachelor's degree in Engineering, Science, or a related field.
- Minimum 5 years of experience in GMP manufacturing or technical support of GMP operations.
- Demonstrated strong performance record and excellent project management skills.
- Strong communication and collaboration skills with the ability to drive accountability.
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
Nice-to-haves
- Experience leading and managing departmental or cross-functional teams.
- Experience in technology transfer and/or facility start-up projects.
- Strong understanding of process risk assessment tools and Quality by Design principles.
- Experience with Lean/Six Sigma methodologies.
- Regulatory inspection presentation experience with external regulatory authorities.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401k plan
- Paid holidays
- Paid time off
- Flexible work arrangements
- Professional development opportunities
