Equipment Qualification Contractor

SeerPharma (www.seerpharma.com) is a consulting firm specialising in Quality and GMP compliance for pharmaceutical, medical device, and life science companies across the Asia-Pacific region. Operating for over 35 years from Melbourne, Sydney, and Singapore, the company provides best-practice advice, training, MasterControl software solutions, and contract labour resources.
SeerPharma supports organisations in ensuring that facilities, equipment, quality systems, and processes meet FDA, PIC/S, TGA, WHO, ISO, ICH, and other regulatory standards. The team works across the product lifecycle, from research and development through manufacturing, logistics, warehousing, and post-market surveillance. Through these services, SeerPharma aims to advance quality and GMP best practices in the APAC region.
Role
The Equipment Qualification Contractor will support SeerPharma's GxP and Engineering Compliance teams in serving our clients, and will be responsible for delivering end-to-end commissioning, qualification, and validation (CQV) activities for GMP manufacturing equipment and utilities. Operating under the requirements of PIC/S PE009-17 (Annex 15: Qualification and Validation), this role ensures all our clients' pharmaceutical production and analytical equipment is fit for purpose, correctly installed, operating within specifications, and capable of consistently producing quality outcomes.
Key Responsibilities
User Requirements & Specifications:Draft, review, and finalise User Requirements Specifications (URS) and Functional Specifications (FS) aligned with PIC/S PE009-17 standards and life-cycle approach.Quality Risk Management (QRM):Facilitate and author Quality Risk Assessments (e.g., FMEA, PHA) for manufacturing equipment and critical utilities in accordance with ICH Q9/PIC/S Annex 20.Define critical quality attributes (CQAs), critical process parameters (CPPs), and critical component design attributes (CAs) to establish test boundaries.Protocol Development (IQ/OQ/PQ):Draft comprehensive Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.Ensure test acceptance criteria directly trace back to URS requirements and risk assessment controls.Protocol Execution:Coordinate and execute IQ, OQ, and PQ protocol testing on-site in GMP environments.Manage thermal mapping, environmental control testing, instrumentation calibration checks, and utility integration as applicable.Deviations & Discrepancy Management:Identify, log, investigate, and resolve protocol deviations, test non-conformances, and engineering punch-list items in real-time.Qualification Reporting & Summary:Author final IQ/OQ/PQ summary reports documenting execution results, data analysis, deviation closures, and final fitness-for-use recommendations.Prepare traceability matrices linking URS items to risk controls and protocol test cases.GMP & Quality Compliance:Ensure strict adherence to Data Integrity principles (ALCOA+) across all test scripts and raw data collection.Ensure compliance with site Quality Management Systems (QMS), standard operating procedures (SOPs), and change control processes.
Key Competencies and Qualifications
Education: Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related scientific discipline.Experience: 3+ years of direct commissioning, qualification, and validation (CQV) experience in a regulated pharmaceutical or biological manufacturing environment.Standards Knowledge: Expert understanding of PIC/S PE009-17 (specifically Annex 15), ICH Q9, and ISPE Baseline Guides (Volume 5: Commissioning and Qualification).Technical Skills:Strong proficiency in drafting URS, Risk Assessments (FMEA), IQ/OQ/PQ protocols, and Traceability Matrices.Practical experience executing testing on process equipment (e.g., autoclaves, bioreactors, fillers, CIP/SIP systems, HVAC, purified water systems).Hands-on knowledge of data loggers, thermal mapping tools (e.g., Kaye Validator), and calibrated test instrumentation.Communication & Documentation: Excellent technical writing skills with strict adherence to Good Documentation Practices (GDP).