MSAT Engineer / Consultant

Responsibilities

• Deliver various projects in the competency area of manufacturing science and technology (MSAT) and related functions such as validation and quality. Potential scope of projects include:
• Author and review Extractables and Leachables (E&L) Risk Assessments.
• Generate strategy for bioburden, endotoxin, buffer / media mixing performance qualification (PQ), media / buffer hold time PQ, etc.
• Support single use material introduction including technical assessment and qualification strategy alignment.
• Plan and execute PQ including authoring reports and results that may include data trending and analysis.
• Author and review other process related qualification and validation activities including in Cleaning Validation (CV), Sterilization-in-Place (SIP), resin lifecycle, etc.
• Troubleshoot cleaning issues and support investigations and CAPA.
• Draft other deliverables within full CQV cycle such as URS, risk assessment and data integrity assessment.

Requirements

• Hold Bachelor's degree in Life Sciences, Engineering or related field.
• Have worked for at least 3 years in pharmaceutical, medical device or related environment.
• Have working competency in the area of Fermentation, Centrifugation, chromatography and/or TFF/UFDF processes.
• Why Join ORKA:
• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

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