Validation & Engineering Group, Inc.
LL01-250609 QC Lab Equipment Validation Specialist
Validation & Engineering Group, Inc., Juncos, Juncos, us, 00777
Overview
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas including Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and related services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Position
Laboratory Equipment Validation Specialist Responsibilities
Develop and execute validation protocols and related documentation (URS, DS, IQ, OQ, PQ). Prepare deviations and generate reports; manage SDLC, Risk Assessment, Data Integrity, FAT & SAT. Provide technical writing and investigations; support regulatory compliance with cGxP guidelines. Work with equipment such as incubators, Kaye Data Loggers, Particle Counter, TOC analyzer, Climet air sampler, Freezers, and Disintegration testers. Utilize Kneat, CDOCS, Maximo. Collaborate with cross-functional teams in direct process/lab environments; extend hours as needed, including weekends/holidays. Qualifications
Bachelor's Degree in Science or Engineering. Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in direct process/laboratory areas. Fully bilingual (English / Spanish) with excellent oral skills. Proficient in MS Windows and Microsoft Office. Strong knowledge of cGxP and regulatory guidance and their application to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, FAT & SAT. Technical writing skills and investigative processes. Available to work extended hours, possibly including weekends and holidays. Job details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x. Get notified about new Quality Assurance Specialist jobs in
Juncos, Puerto Rico .
#J-18808-Ljbffr
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas including Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and related services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Position
Laboratory Equipment Validation Specialist Responsibilities
Develop and execute validation protocols and related documentation (URS, DS, IQ, OQ, PQ). Prepare deviations and generate reports; manage SDLC, Risk Assessment, Data Integrity, FAT & SAT. Provide technical writing and investigations; support regulatory compliance with cGxP guidelines. Work with equipment such as incubators, Kaye Data Loggers, Particle Counter, TOC analyzer, Climet air sampler, Freezers, and Disintegration testers. Utilize Kneat, CDOCS, Maximo. Collaborate with cross-functional teams in direct process/lab environments; extend hours as needed, including weekends/holidays. Qualifications
Bachelor's Degree in Science or Engineering. Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in direct process/laboratory areas. Fully bilingual (English / Spanish) with excellent oral skills. Proficient in MS Windows and Microsoft Office. Strong knowledge of cGxP and regulatory guidance and their application to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, FAT & SAT. Technical writing skills and investigative processes. Available to work extended hours, possibly including weekends and holidays. Job details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x. Get notified about new Quality Assurance Specialist jobs in
Juncos, Puerto Rico .
#J-18808-Ljbffr