Commissioning Qualification CQ Engineer
Commissioning Qualification CQ Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
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 equipments such as Centrifuge Transfer pipings 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 GMPregulated 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 crossfunctional 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:
- Bachelors or masters 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).
- Handson experience with C&Q protocols and riskbased 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 problemsolving skills and ability to work in a fastpaced environment.
- Excellent communication and teamwork skills.
- Experience with largescale multisite qualification projects.
- Knowledge of Data Integrity and Computer System Validation (CSV) principles.
- Certification in C&Q validation or regulatory compliance is a plus.
Employment Type
Full Time
