Senior Associate Manufacturing Engineer

Role Summary

Senior Associate Manufacturing Engineer supports the design and development of manufacturing processes and provides maintenance and reliability support to ensure timely access to medicines. Works with an engineering team to accelerate delivery of medicines by envisioning new possibilities and taking decisive action.

Responsibilities

• Supports manufacturing operations on the production floor for various equipment and processes with varying levels of automation.
• Point of Contact for the execution and issue resolution associated with process equipment commissioning, qualification and validation.
• Owns troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
• Delivers right-first-time execution and continuous improvement; monitor, identify and communicate process and compliance trends in real time.
• Participates in authoring controlled documentation (SOPs, Manufacturing Batch/Formulation Records, forms, etc.).
• Collaborates with Subject Matter Experts for manufacturing operations in support of investigations and CAPA implementations.
• Maintains current on assigned training.
• Leads Lean Manufacturing, Sustainability and Operational Excellence initiatives; drives continuous improvement across manufacturing areas.
• Leads escalation through management when operations, safety, equipment, product supply, or quality compliance are at risk.
• Generates work requests when facility/manufacturing equipment issues arise; supports maintenance to resolve; serves as point of contact for emergency work orders.
• Proficient with enterprise systems supporting manufacturing operations (e.g., SAP, LIMS, AMPS, PDOCS, QTS).
• Identifies escalation needs for risks to operations, safety, equipment, product supply, or quality/compliance.
• Leads cross-functional project teams through high-risk technical assessments and develops complex engineering solutions.
• Leads and coaches junior Manufacturing Engineers through complex troubleshooting, investigations, and projects.
• Oversees supplier technical and corporate audits.
• Shares knowledge within the team through established systems.

Qualifications

• Minimum: Bachelor's degree with 2+ years experience; OR Master's degree with 0+ years; OR Associate's degree with 6 years; OR high school diploma with 8 years of relevant experience.
• Demonstrated knowledge of Good Manufacturing Practices and experience in a pharmaceutical environment.
• Proficiency in project-oriented administration, cost control, and management; strong technical management and organizational skills; good leadership and communication abilities.

Skills

• Automation experience (preferred), equipment validation, and knowledge of manufacturing processes and equipment.
• Problem-solving skills; ability to facilitate project meetings and manage project finances.
• Safety and biosafety compliance commitment.
• Strong interpersonal and collaboration skills for cross-functional work.

Education

• Bachelor's degree required (engineering or related field).

Additional Requirements

• Physical/Mental: Lifting, sitting, standing, walking, bending; ability to perform mathematical calculations and complex data analysis.