Samuel O' Callaghan PSC Biotech

Samuel O’Callaghan is an experienced business director with over 20 years in managing GxP manufacturing facilities across pharmaceutical and biotech industries. His core strengths include CQV (Commissioning, Qualification, and Validation), reliability engineering, project delivery, and operational excellence. He holds a Bachelor of Mechanical Engineering from Monash University.

He has held leadership roles at CSL, Grifols, Bachem, Nestlé, and Toyota, gaining a broad, cross-industry perspective that enhances his approach to regulated operations and technical excellence.

As Managing Director for PSC Biotech® (ANZ), Samuel leads multidisciplinary teams that provide comprehensive engineering, technical and GMP consulting services. From project planning and design, to commissioning and qualification, through to operational readiness and excellence.

Samuel also co-authored the ISPE Good Practice Guide: Critical Utilities GMP Compliance (2020), contributing expert insights into utility systems essential for sterile processing. His work reflects a deep commitment to advancing compliance and innovation in GXP and aseptic environments.