Job Description

Department Details
Role Summary
BU: Biosimilar
Process Engineering Lead - Mammalian cell culture and downstream processing:
The Process Engineering lead will be responsible for technology transfer projects from bench / pilot scale to manufacturing scale, resolve facility and process fitment challenges during the scale up and regular manufacturing, propose and manage the qualification and validation needs arising out of changes in facility and equipment.
The candidate should be proficient in process scale up factors from bench to commercial for Cell culture, Chromatography, ultrafiltration, normal flow filtration, and Nanofiltration operations. Apart from these the candidate will also be responsible for facility and equipment related deviations / investigations and proposing engineering solutions to mitigate operational risks during the manufacturing operations. This will also involve qualification / validation as required by various regulatory agencies.
Basic Qualifications:
Bachelor's degree in Chemical Engineering / Biotechnology with minimum ten years of process engineering and project management experience in a manufacturing, pharmaceutical or biotech environment. Demonstrated ability and understanding on the development and execution of qualification protocols (IQ, OQ and PQ) and other validation lifecycle documents. Candidate should be proficient in the use of Trackwise, MS Projects and SAP for organising and tracking the various projects and GMP documents.
Key Responsibilities
BU: Biosimilar
Process Engineering Lead - Mammalian cell culture and downstream processing:
The Process Engineering lead will be responsible for technology transfer projects from bench / pilot scale to manufacturing scale, resolve facility and process fitment challenges during the scale up and regular manufacturing, propose and manage the qualification and validation needs arising out of changes in facility and equipment.
The candidate should be proficient in process scale up factors from bench to commercial for Cell culture, Chromatography, ultrafiltration, normal flow filtration, and Nanofiltration operations. Apart from these the candidate will also be responsible for facility and equipment related deviations / investigations and proposing engineering solutions to mitigate operational risks during the manufacturing operations. This will also involve qualification / validation as required by various regulatory agencies.
Basic Qualifications:
Bachelor's degree in Chemical Engineering / Biotechnology with minimum ten years of process engineering and project management experience in a manufacturing, pharmaceutical or biotech environment. Demonstrated ability and understanding on the development and execution of qualification protocols (IQ, OQ and PQ) and other validation lifecycle documents. Candidate should be proficient in the use of Trackwise, MS Projects and SAP for organising and tracking the various projects and GMP documents.
Educational Qualifications
Required Education Qualification: B.E
Required Experience: 10 - 14 years

Skills Required