Msat Engineer / Consultant

Key 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.