Process Engineer – Technical Services (Equipment & Projects)
About the opportunity
Join a global pharmaceutical company as a Process Engineer – Technical Services (Equipment & Projects).
This is a 12-month contract opportunity.
In this role, you will be responsible for supporting the qualification and validation of manufacturing equipment, utilities, and systems, ensuring they remain in a validated state.
You will collaborate with cross-functional teams, execute validation protocols, and support regulatory compliance, contributing directly to operational readiness and process excellence.
Responsibilities
Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
Conduct risk assessments (e.g., FMEA) to define validation strategies and critical parameters.
Maintain the validated condition of manufacturing equipment, clean utilities, and process support systems.
Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
Support qualification of clean utilities (e.g., WFI, clean steam, compressed air, HVAC).
Ensure proper validation of automation and control systems (SCADA, PLC, MES) as required.
Investigate validation deviations and non-conformances, implementing corrective and preventive actions (CAPAs).
Evaluate the impact of equipment modifications and process changes on the validated state.
Prepare and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
Ensure compliance with Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.
Requirements
Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Life Sciences.
5–7 years of experience in validation, equipment qualification, or technical services within a sterile injectables manufacturing.
Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
Experience with validation lifecycle (URS, FAT/SAT, PQ) and computerized system validation (CSV).
Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
Knowledge of data integrity principles (ALCOA+).
Practical experience with environmental monitoring systems and cleanroom qualification.
Knowledge of autoclave and depyrogenation tunnel operation.
Experience with load preparation, thermocouple calibration/placement, and handling biological indicators.
Preferred
Familiarity with endotoxin spiking procedures.
Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
Knowledge of Process Analytical Technology (PAT) and digital validation tools.
#J-*****-Ljbffr