Commissioning & Qualification (C&Q) Engineer
78 Days Old
- 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.
- 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.
- Location:
- Harrisburg
