
Retired Professional
1 day ago
Position Overview:
We are seeking highly experienced and seasoned Process Engineering Consultants from the pharmaceutical and biotechnology industry to support our precision fermentation project. A retired professional who possesses deep domain expertise in upstream and downstream areas and is interested in consulting engagements, to share their knowledge, provide mentorship, and contribute to process optimization, facility design, technology transfer, and regulatory compliance.
Essential Duties and Responsibilities:
Provide expert guidance on fermentation process design, development, and optimization for active ingredient production from microbial metabolites.
Assist with GMP compliance, validation, and regulatory readiness for FDA, EMA, and other global regulatory bodies.
Review and advise on technology transfer, scale-up, and commissioning activities.
Contribute to facility design and layout planning for new or upgraded production sites.
Identify and troubleshoot bottlenecks or inefficiencies in existing manufacturing processes, guide and oversee continuous improvement programmes.
Mentor junior engineers and collaborate with cross-functional teams (QA, QC, RA, Operations).
Support clients with risk assessments, gap analysis, and process improvement initiatives.
Assist in developing or reviewing SOPs, URS, and validation protocols.
Qualifications/Competencies/Position Requirements:
Bachelors / Masters Degree / Ph.D in Biotechnology/Chemical Engineering/Process Engineering Pharmaceutical Engineering, or related field.
25+ years of experience in Industrial Biotechnology and process engineering.
Demonstrated knowledge of GMP regulations, ICH guidelines, and global regulatory standards.
Proven experience in facility design, process scale-up, technology transfer, and validation.
Excellent communication and documentation skills.
Ability to work independently as a consultant or as part of a multidisciplinary team.
Retired professionals from leadership roles (e.g., Director, VP, Principal Engineer) are strongly encouraged to apply.
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