Responsibilities:

Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities.
Perform system startup, debugging, and initial testing of process and utility systems.
Ensure that systems are installed and operating according to design specifications.
Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning.
Review and verify system documentation, such as P&IDs, wiring diagrams, and datasheets, to ensure compliance.
Experience in Commissioning & Qualification of Upstream and Downstream process equipment's such as Centrifuge, Transfer piping's, Buffer Tanks, Stainless Steel and Single Use Bio reactors, Filtration systems, Chromatography systems etc.
Experience in Commissioning of Black Utilities such as Waste Neutralization system, Chilled Water system, Portable Water system, Natural gas system, Plant Steam etc.
Lead and execute commissioning and qualification (C&Q) activities for GMP-regulated facilities, utilities, and equipment.
Develop and review C&Q documentation, including User Requirements Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform risk assessments, including Component Level Impact Assessment (CLIA) and System Level Impact Assessment (SLIA).
Ensure compliance with GAMP, ISPE guidelines, and applicable regulatory requirements (e.g., FDA, EMA).
Redline engineering drawings and participate in system walkdowns.
Execute HVAC, Process Gas, Cleanroom, and Temperature Mapping qualification protocols.
Collaborate with cross-functional teams, including engineering, QA, and validation teams.
Prepare and present C&Q summary reports to stakeholders.
Contribute to continuous improvement initiatives related to C&Q processes.

Requirements:

Bachelor's or master's degree in engineering (Mechanical, Chemical, Biopharmaceutical, or related field).
Minimum of 5+ years of experience in Commissioning & Qualification within Life Sciences (Pharmaceutical, Biotech, or Medical Device industry).
Strong knowledge of regulatory guidelines (FDA, EMA, ISPE, GAMP).
Hands-on experience with C&Q protocols and risk-based qualification approaches.
Experience with qualification of HVAC systems, clean utilities, bioreactors, process gases, clean air equipment, controlled temperature equipment, environmental monitoring systems, and system drawings verification.
Proficiency in reviewing and redlining engineering documents.
Strong problem-solving skills and ability to work in a fast-paced environment.
Excellent communication and teamwork skills.

Experience with large-scale, multisite qualification projects.
Knowledge of Data Integrity and Computer System Validation (CSV) principles.
Certification in C&Q, validation, or regulatory compliance is a plus.

Katalyst HealthCares and Life Sciences

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