ECQ Engineer
2 weeks ago
Responsibilities of the ECQ Engineer
- Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products
- Develop, execute, and document equipment qualification protocols and test plans in accordance with cGMP regulations and industry standards
- Commission new laboratory equipment and decommission old laboratory equipment
- Perform IQ OQ PQ on new laboratory equipment
- 3+ years of experience in ECQ or related field in a pharmaceutical manufacturing environment
- Experience with lab equipment commissioning and decommissioning, HPLC, UPLC, and CSV
- Knowledge of FDA and EU cGMP regulations, ICH guidelines, GALP, GLP, GDP, and other industry best practices
- Bachelor's or higher degree in engineering or related technical field
- Salary Range : $60 - $65 / hour
- Benefits : Medical, Dental, Vision, 401k match, Paid Holidays, and PTO
Keywords: equipment, commissioning, qualification, decommissioning, ECQ, IQOQPQ, IQ, installation qualification, OQ, operational qualification, PQ, performance qualification, process validation, lab, laboratory equipment, HPLC, high performance liquid chromatography, UPLC, ultra performance liquid chromatography, ultra-performance, high-performance, chromatographic system, CSV, computer system validation, FDA, IHC, compliance, regulatory, inspections, reporting, control systems, MES, manufacturing execution systems, GALP, good automated laboratory practices, GLP, good laboratory practices, GMP, good manufacturing practices, QC, quality control, software upgrades, SOPs, standard operating procedures, work instructions, safety protocols, solutions, equipment commission, calibration, repair, maintenance, cGMP, current good manufacturing practice, GXP, SDLC, software development life cycle, 21CFR part 11, GDP, good documentation practice, pharma, pharmaceutical, CMMS, computerized maintenance management system, CMS, calibration management system
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