Senior Process Engineering Specialist
3 weeks ago
Key Responsibilities
- Manage the transition of production methods from the development phase to full-scale manufacturing, ensuring effective integration and successful scaling.
- Improve and optimize manufacturing workflows to enhance efficiency, product quality, and yield, utilizing engineering principles and statistical analysis.
- Provide technical guidance and support for resolving process challenges, deviations, and investigations, employing root cause analysis techniques for prompt resolution.
- Collaborate with cross-functional teams, including Process Development, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure compliance with regulatory standards and company policies.
- Develop technical documentation such as Technology Transfer Plans, Gap Assessments, Process Flow Diagrams, Summary Reports, and Process Failure Mode Effects Analyses (FMEAs).
- Lead or support validation initiatives, including process validation, equipment qualification, and cleaning validation, to fulfill regulatory requirements.
- Stay informed about industry advancements, emerging technologies, and regulatory guidelines in pharmaceutical manufacturing, applying this knowledge to foster continuous improvement.
- Guide junior engineers by providing technical mentorship and training to facilitate their professional growth.
- Participate in internal and external audits, inspections, and regulatory submissions, offering technical expertise and documentation support as necessary.
Qualifications
- Bachelor's or Master's degree in Engineering or a related scientific discipline
- Over 5 years of experience in the Pharmaceutical or Biopharmaceutical sector
- Proven experience with Technical Transfers in the pharmaceutical industry
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