At-a-Glance:

\nAre you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a C&Q Engineer.

Position Type:

\nContract\nOnsite\nRequired\n

Required Qualifications:

\nBachelor's degree in Engineering, Life Sciences, or similar.\n3-8+ years of CQV/Validation experience in pharma/biotech.\nMandatory Technical experience.\nExperience in:\nAseptic or sterile manufacturing environments.\nExposure to:\nIsolator systems and barrier technologies.\nCleanrooms and HVAC systems.\nFamiliarity with:\nIOQ/PQ execution.\nCommissioning activities.\n

Preferred Experience:

\nHands-on experience with:\nVHP decontamination cycles.\nSmoke studies (AVS).\nExperience with digital validation tools (e.g., KNEAT).\n

Soft Skills:

\nStrong attention to detail.\nAbility to work in field execution environments.\nTeam-oriented mindset.\nGood documentation and communication skills.\n

Responsibilities:

\nC&Q Engineer will support execution of commissioning and qualification activities for a CAR-T aseptic processing facility implementing advanced isolator systems.\nRole will focus on protocol development, field execution, data collection and reporting.\n

Documentation Preparation:

\nDevelop CQV documentation in

KNEAT:

URS, SIA, DQ

\nFAT/SAT protocols\nCommissioning protocols (PCOM/CTP)\nIOQ and PQ protocols [Exhibit A...T Isolator | Word]\n

Support:

\nTraceability matrices\nRisk assessments (CARA/CAM)\n

Field Execution:

\nExecute CQV activities onsite:\nFAT/SAT support\nCommissioning tests\n

IOQ / PQ / EMPQ

execution [Exhibit A... T Isolator | Word]\n

Perform:

\nWalkdowns\nTest execution and data recording\nDeviations management\n

Isolator & Aseptic Validation:

\nSupport qualification of isolator systems\n

Execute:

\nVHP cycles (development, qualification, verification) [Exhibit A...T Isolator | Word]\nSmoke studies (air visualization - static/dynamic)\nAssist in:\nEnvironmental Monitoring PQ\nDigital Execution\nExecute protocols in KNEAT\nSupport\nReview cycles\nApproval workflows\nEnsure data integrity and compliance\nReporting\nContribute to:\nSummary reports\nQualification reports\nDefect/punchlist closure\nGet in

Touch:

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