SME Manufacturing Engineer

Key Responsibilities:

1. Deviation Management:

   • Lead root cause investigations using Six Sigma tools (e.g., DMAIC, 5M, Cause & Effect).
   • Develop corrective and preventive actions (CAPA), ensuring robust follow-up.
   • Collaborate with cross-disciplinary teams to resolve issues efficiently.

2. Reporting & Compliance:

   • Proactively track and resolve deviations to meet quality timelines.
   • Communicate findings and progress to stakeholders, including senior management and auditors.
   • Act as a Subject Matter Expert (SME) during audits.

3. Continuous Improvement:

   • Identify and execute process improvement initiatives.
   • Propose technical and organizational enhancements to optimize operations.

Qualifications:

• Education: Bachelor’s/Master’s in Engineering.
• Experience: 3–5 years in biotech/pharmaceutical manufacturing with a focus on process operations, quality, or deviation management.
• Technical Skills: Proficiency in cGMP environments, biotechnological processes (USP/DSP), and Six Sigma methodologies.

Key Competencies:

• Analytical and detail-oriented problem-solving.
• Excellent cross-functional communication skills.
• Adaptability and initiative in fast-paced environments.
• Fluency in French and English.

Preferred:

• Lean/Six Sigma certifications.
• Experience with QMS tools (e.g., Trackwise, Veeva Vault) and statistics software (e.g., MiniTab).

Note: Occasional work in controlled environments with specific gowning requirements is required.