Process Engineer
The Senior Process Engineer will lead the design, optimization, and scale‑up of manufacturing processes for advanced drug delivery systems. This role requires proven industry experience in pharmaceutical or biotech manufacturing, with a strong track record of technology transfer, process validation, and GMP compliance. The Senior Process Engineer will act as a technical leader, mentoring junior engineers and driving cross‑functional collaboration to ensure robust, reproducible processes that meet regulatory and commercial requirements.
Key Responsibilities
- Process Leadership & Development
- Lead the design, implementation, and optimization of manufacturing processes for sterile injectables and microsphere formulations.
- Drive scale‑up and validation activities for clinical and commercial production.
- Provide technical leadership in troubleshooting and root cause analysis.
- Technology Transfer & Industrialization
- Oversee transfer of processes from R&D to GMP manufacturing.
- Ensure documentation (batch records, SOPs, validation protocols) meets regulatory and operational standards.
- Act as the primary technical contact for CDMOs and manufacturing partners.
- Quality & Compliance
- Ensure processes comply with EU GMP, ICH, and FDA standards.
- Lead deviation investigations, CAPAs, and risk assessments.
- Provide process data and technical reports for regulatory submissions.
- Cross‑Functional Collaboration & Mentorship
- Partner with formulation scientists, analytical development, QA/RA, and supply chain teams.
- Contribute technical expertise to CMC dossiers and stability programs.
- Mentor junior engineers and foster a culture of continuous improvement.
- Represent process engineering during audits, inspections, and regulatory interactions.
Qualifications
- MSc/PhD in Chemical Engineering, Pharmaceutical Technology, or related field.
- Minimum 5-8 years of hands‑on industry experience in pharmaceutical/biotech process engineering.
- Strong background in sterile injectables, microsphere technologies, or complex drug delivery systems.
- Deep knowledge of GMP, validation, and regulatory frameworks (EU/ICH/US).
- Demonstrated success in technology transfer, scale‑up, and process optimization within industrial settings.
- Proven leadership skills, with experience mentoring engineers and managing cross‑functional projects.
- Excellent problem‑solving, documentation, and communication abilities.
What the Organization Offers
- Opportunity to lead at the forefront of drug delivery innovation.
- Collaborative, international environment with exposure to cutting‑edge technologies.
- Professional growth through leadership responsibilities and regulatory interface.
- Competitive compensation and benefits package.
FAQs
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