Commissioning, Qualification & Validation Engineer/Specialist

Compliance Technology Group, Inc. “CTG, Inc”(West Chester,PA); Lafayette (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Compliance Technology Group, Inc. is seeking Commissioning/Validation Specialists/Engineers to support startup, commissioning and validation activities for GMP construction projects in FDA-regulated industries including biopharma, medical devices and diagnostics.

The Lafayette, Indiana area client requires developing and executing URS, FRS, DDS, FAT, SAT, CSV, OQ and PQ documents, while maintaining clear communication with the Project Manager and CTG leadership.

Qualifications

• Bachelor's or master's degree in biology, engineering, chemistry, or related subject with 1+ years of experience in the biopharm industry.
• A thorough understanding of the GMP regulatory environment, validation, and associated subjects.
• An ability to work independently.
• Excellent verbal and written communication skills.
• Proficiency in Windows and Microsoft Office applications.

Responsibilities

• Develop and/or execute URS (User Requirement Specification), FRS (Functional Requirement Specification), DDS (Detailed Design specification), FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), CSV (Computer System Validation), OQ (Operational Qualification), PQ (Performance Qualification).
• Maintain direct communication with Project Manager or CTG upper-level management and client to ensure services are in compliance with client and federal policies and procedures.

Skills

Verbal communication

Written communication

Independent working

Windows proficiency

Microsoft Office proficiency

Education

Bachelor's or Master's degree in biology, engineering, chemistry, or related subject

Tools

Windows OS

Microsoft Office

Job description

Compliance Technology Group, Inc., is currently seeking Commissioning/Validation Specialists/Engineers to work on an innovated GMP construction project focused on pharmaceutical processes. Qualified candidates will participate in startup, commissioning, and validation activities for our clients within FDA regulated industries including pharmaceutical, biotechnology, medical device, and medical diagnostic. The current need is for a client in the Lafayette, Indiana area.

Commissioning/Validation Specialists/Engineers will be able to develop and/or execute the following documents:

• URS (User Requirement Specification)
• FRS (Functional Requirement Specification)
• DDS (Detailed Design specification)
• FAT (Factory Acceptance Testing)
• SAT (Site Acceptance Testing)
• CSV (Computer System Validation)
• OQ (Operational Qualification)
• PQ (Performance Qualification)

Requirements:

Other responsibilities include maintaining direct communication with Project Manager or CTG upper-level management and client to ensure our services are in compliance with client and federal policies and procedures.

Bachelor's or master's degree in biology, engineering, chemistry, or related subject with 1+ years of experience in the biopharm industry

• A thorough understanding of the GMP regulatory environment, validation, and associated subjects
• An ability to work independently
• Excellent verbal and written communication skills
• Proficiency in Windows and Microsoft Office applications