Senior Process Engineering Manager
Department: MSAT-MTS
Reports To: Senior MTS manager We're excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine! Click to learn more. What You'll Do:
- Manage the process equipment team for upstream and downstream processes as well as for solution preparation.
- Strives to Implement a continuous Improvement mindset and standardization across the team and in an alignment with stakeholders (Manufacturing, Quality, Global teams...).
- Implement Continuous Process Verification (CPV) and associated control plans
- In charge of process control of manufacturing equipment ensuring production stability and performance level
- Technical support and troubleshooting for critical manufacturing operations during Engineering and GMP processing
- Lead implementation of new technologies in production.
- In charge of manufacturing equipment maintenance plan definition and good execution in alignment with Maintenance planner
- Support creation and review of technical documentation including, batch records, and reports related to engineering, GMP and PPQ runs.
- Support CQV activities bringing expertise and leadership
- Bachelor's degree in engineering science or related program with 5+ years relevant experience
- At least 3+ years of Experience in managing technical teams in bio-pharma industry
- Experience with equipment commissioning, qualification, and validation activities
- Operation in process control systems and development of automation recipes
- Ability to organize, analyze/interpret, and effectively communicate data.
- Basic knowledge in statistics and more specifically with SPC
- Familiar with Continuous Improvement approach and methodologies (i.e. RCA , DMAIC...)
- Authoring technical and quality documentation within GMP systems
- Experience in process and equipment risk assessments using industry-standard tools (e.g. FMEA)
- Experience with process analytical technology implementation and continued process Verification
- Understanding chromatography, and filtration processing equipment and operations used to manufacture biotherapeutics
- Good interpersonal, team, and collaborative skills are a must
- Excellent oral and written communication skills in both English and French
- Additional Preferred Qualifications:
- Applies knowledge to solve complex technical problems; may apply novel approach that provides significant technology advancement
- Ability to navigate global regulatory CMC documents
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