Position Summary The
Senior Engineer provides advanced technical leadership in support of manufacturing operations, ensuring process robustness, compliance, and continuous improvement. This role acts as a key contributor in process optimization, deviation management, and cross-functional initiatives, while serving as a subject matter expert in designated technical areas within a regulated environment.
Key Responsibilities • Own
change controls for manufacturing process changes
• Support major/trend
deviation investigations throughout the whole lifecycle including
Root Cause Analysis investigation, determination of
Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
• Support
Risk Assessments exercises and
Microbial assessment evaluations.
• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
• Provide commercial support when needed and assist on the floor troubleshooting.
• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
• Assist and provide guidance during
MBR (Master Batch Record) creation/revisions.
• Perform assessment to support process, automation, or equipment modification or implementation of special projects
• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Complete assessments for
CAPA applicability requests from other plants/sites
• Complete assessment for new or changes in
BOM's (Bill of Materials)
• Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.
Minimum Qualifications - Doctorate Degree, OR
- Master's Degree with 2 years of Engineering experience, OR
- Bachelor's Degree in Engineering with 4 years of Engineering experience
- Educational background in Engineering and/or Life Sciences.
- Strong experience in bioprocessing unit operations is preferred.
Preferred Qualifications - Expertise in Root Cause Analysis tools, including:
- Fishbone Diagram
- 5 Whys
- Kepner-Tregoe
- Six-Box Model
- Knowledge of Lean Manufacturing practices.
- Experience working in regulated environments (GMP) with strong knowledge of Good Documentation Practices (GDP).
- Proficiency with systems such as:
- TrackWise
- Spotfire
- CDOCS
- Process monitoring platforms
- Strong collaboration skills across Manufacturing, Quality, and Process Development.
- Excellent technical writing, presentation, and communication skills.
- Bilingual proficiency in English and Spanish.
