Subject Matter Expert-Process- Peptide

Role & responsibilities

As a Subject Matter Expert in Peptide, candidate should possess following as a minimum:

• Strong Technical Skills in carrying out basic and detailed engineering work. The candidate should be experienced in handling Peptide projects.
• Should be able to prepare Process Flow Diagrams (PFDs) and Piping and Instrumentation Diagrams (P&IDs)
• Should have strong knowledge on layout designing of Peptide plants
• Should be able to independently carry out Capacity Mapping of Peptide Plants
• The candidate should possess sound knowledge on equipment selection criteria for Solid Phase Peptide Synthesizer, Lyophilizer, PREP HPLC, DAC Column, Rotary evaporator etc.
• Should have knowledge on latest ISPE Guidelines
• Should be aware of regulatory requirements of USFDA, MHRA, WHO, TGA etc.

Preferred candidate profile

• Performing All process engineering calculations like heat & mass balance, Utility sizing (Clean & Black), Thermal rating of heat exchangers and hydraulics, line sizing, Pump Hydraulics
• Vendor Document Review
• Reviewing all aspects of design and construction for consistency and safety, including leading HAZOP and PHA Reviews
• Possess thorough knowledge on containment techniques and be able to perform Containment Studies.
• Provide guidance in GMP reviews.

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