Join to apply for the MSAT Bioprocess Engineer role at Piramal Pharma Ltd.
Key Responsibilities:
* Prepare GMP batch records for use in GMP manufacturing processes.
* Review, approve, and issue manufacturing documentation.
* Determine scale-up criteria from development to manufacturing scale.
* Generate process mass balances and flow diagrams.
* Identify, design, and define large-scale manufacturing equipment.
* Define materials for use in a GMP manufacturing environment.
* Generate quality documentation for raw materials and equipment.
* Work within the Piramal quality system to initiate, manage, and evaluate requests for change.
* Perform investigations, close CAPAs and deviations.
* Project manage all aspects of the introduction of processes to manufacturing.
* Perform risk assessments in alignment with ICH Q9.
* Evaluate process materials for suitability for use in manufacturing.
Competencies:
* Good time management skills.
* Strong team working ability.
* Good communication skills.
* High attention to detail.
* Good problem-solving skills.
* Good decision-making skills.
Qualifications:
Essential Qualifications:
Preferably BSc (Hons) in Science or Engineering discipline (or equivalent).
Essential Experience:
* Proven GMP biologics manufacturing or process development experience.
* Strong planning, organization, and stakeholder management skills.
* Experience with process scale-up, transfer, and manufacturing support.
* Ability to meet project deadlines.
* Effective communication across different levels of the organization.
* Experience in evaluating materials for process suitability and writing GMP batch records.
Desirable Experience:
* Experience in commercialization of biological medicines and process validation.
* Experience in process improvement and mapping.
* Sourcing and validation of large-scale process equipment.
Additional Details:
* Seniority Level: Entry level
* Employment Type: Full-time
* Job Function: Engineering and IT
* Industry: Pharmaceutical Manufacturing
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