CQV / MSAT Engineer / Consultant (Pharmaceutical Process)

Support process-related projects including but not limited to Technology Transfer, Cleaning Validation (CV), Sterilization-in-Place (SIP) PQ, Process Qualification and Process Validation (PV) / Process Performance Qualification (PPQ).
Draft Technology Transfer documentations such as facility fit assessment, control strategy, etc.
Draft and review CQV and/or technology transfer deliverables including but not limited to risk assessment, technical justification / strategy / approach and qualification / validation protocols.
Support CQV / PQ / PPQ activities.
Support process comparability, resin lifecycle management, stability study and other process related activities.

Hold Bachelor’s degree in Life Sciences, Engineering or related field.
Have worked for at least 5 years in pharmaceutical, medical device or related environment.
Have either pharmaceutical manufacturing or MSAT experience.
Have working competency in the area of Fermentation, Centrifugation, chromatography and/or TFF/UFDF processes.
Have very good understanding of the science behind manufacturing operations.
Have good understanding of regulatory requirements and relevant industry best practice.
Preferably have working knowledge of DeltaV including for logics such as handshakes and prompts.

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. Grown in breadth and depth of both technical knowledge and compliance understanding.
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.

Job Description