Validation & Engineering Group, Inc.
MF02-050625 Qualification Scientist - QA Lab - Automation and CQV Projects
Validation & Engineering Group, Inc., Barceloneta, Barceloneta, us, 00617
MF02-050625 Qualification Scientist - QA Lab - Automation and CQV Projects
4 days ago Be among the first 25 applicants Validation & Engineering Group, Inc.
(V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries, including Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking an experienced Commissioning, Qualification, and Validation (CQV) Scientist to qualify equipment within a Quality Assurance (QA) Laboratory. The ideal candidate will have a strong background in CQV, ensuring compliance with Good Manufacturing Practices (GMP), and delivering projects on time and within budget. Responsibilities
Qualify laboratory equipment and systems in compliance with GMP standards. Develop and execute Design Documentation (URS, DS), IQ, OQ, PQ protocols, deviations, and reports. Participate in risk assessments, Data Integrity, Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT). Ensure laboratory automation systems are validated and compliant. Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related field. Minimum of 5 years of project management experience in a GMP-regulated laboratory environment. Proven experience with laboratory automation systems and CQV processes. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines. Proficiency in MS Windows and Microsoft Office applications. Technical writing skills and experience with investigations processes. Availability to work extended hours, including weekends and holidays. Additional Information
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 Laboratory Scientist jobs in
Barceloneta, Puerto Rico .
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4 days ago Be among the first 25 applicants Validation & Engineering Group, Inc.
(V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries, including Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking an experienced Commissioning, Qualification, and Validation (CQV) Scientist to qualify equipment within a Quality Assurance (QA) Laboratory. The ideal candidate will have a strong background in CQV, ensuring compliance with Good Manufacturing Practices (GMP), and delivering projects on time and within budget. Responsibilities
Qualify laboratory equipment and systems in compliance with GMP standards. Develop and execute Design Documentation (URS, DS), IQ, OQ, PQ protocols, deviations, and reports. Participate in risk assessments, Data Integrity, Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT). Ensure laboratory automation systems are validated and compliant. Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related field. Minimum of 5 years of project management experience in a GMP-regulated laboratory environment. Proven experience with laboratory automation systems and CQV processes. Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines. Proficiency in MS Windows and Microsoft Office applications. Technical writing skills and experience with investigations processes. Availability to work extended hours, including weekends and holidays. Additional Information
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 Laboratory Scientist jobs in
Barceloneta, Puerto Rico .
#J-18808-Ljbffr