Job Title / Industry: CQV Engineer / CQV Engineer II (Pharmaceuticals)
Main Office Location: Athens, GA (USA)
Terms: Full-time
Salary / Rate: Compensation will be commensurate of CQV experience / expertise level and applicable skills.
Special Requirements: Frequent, required travel within and around the Atlanta/Athens and surrounding metro GA areas.
About Us
Triad Consulting Solutions (TCS) provides construction, engineering & design, and CQV project management services for capital investment initiatives. Our team specifically caters to clients in the pharmaceuticals, biotechnology, and regulated life sciences industries (USDA and USFDA). We are a fast-growing, specialty consulting firm that offers a flexible work environment and superior growth opportunities. Currently, TCS is looking for a motivated, self-accountable engineer with an experienced background in commissioning, qualification and validation (CQV) roles.
About the Role
The CQV Engineer, or CQV Engineer II (based on experience level), will plan and schedule qualification projects based on client’s needs and requirements. The CQV Engineer will ensure schedules are executed on time and in full, and service costs are within budgeted constraints of each project. The Engineer must be able to routinely develop, perform, and report qualification activities and documentation in accordance with cGxP concepts and regulatory requirements. This role should be self-sufficient, with auxiliary support from the CQV Engineering Manager.
Key Responsibilities
Manage work deliverables on multiple ongoing projects at one time (multitasking).
- Responsible for identifying and generating applicable validation lifecycle documents for a variety of applications – including, but not limited to: Design Qualifications, Validation Plans, IQ/OQ/PQ’s, Deviation Reports, Risk Assessments, and Protocol Reports.
- Drive completion of commissioning activities on GMP and non-GMP facilities, utilities, and equipment in compliance with clients’ needs and USFDA / USDA regulations, as required.
- Routinely execute Facility, Utility, and Equipment (FUE) qualifications (installation / operational / performance / etc.) in GMP environments. • Review completed protocols for completeness, cGMP compliance and data acceptability.
- Conduct regular project touchpoint meetings with key project stakeholders – working closely and communicating well within cross-functional teams to deliver project on time.
- Provides CQV deliverables on time, in full – effectively mitigating or communicating potential project obstacles.
Optimal Candidate Requirements
Education: Bachelor’s degree in relevant scientific discipline (Engineer, Chemistry, Computer Systems, or other related sciences) required – equivalent experience in regulated life sciences will be considered. Advanced degrees are a plus.
- Minimum of 1 to 5 years of experience in facility, utility, and equipment qualification. Preferred 3+ years of experience in regulated pharmaceutical manufacturing industry.
- Experienced in sterile manufacturing equipment validation (API processing equipment).
- Consistently demonstrated validation proficiencies in previous roles, with knowledge consistent of a subject-matter expert in one or more areas of validation: equipment qualification, critical utilities and facilities commissioning / qualification, cleaning validation, process validation and computer systems validation.
- Ability to manage quality representation on intermediate-to-complex technical projects. • History of using standard quality management systems – platforms for tracking/reporting change controls, CAPA’s, deviations, investigations, etc.
- Must have excellent verbal communication and technical writing skills – including ability to keep detailed files, project notes, and project schedules.
- Experienced in project planning, execution, and closeout.
- Experience / familiarity with common industry guidelines and regulations: 9CFR, 21CFR Parts 210 & 211, 21CFR Part 11, ICH, etc.
- Proficiency in MS Suite (Word, Excel, PowerPoint, etc.).
- Experience with temperature mapping (with data loggers, thermocouples, etc.), aseptic gowning, and automation troubleshooting are attractive features.
Further Job Details
- Reliable transportation is critical – job role will frequently visit clients’ sites to complete project deliverables and must be able to reach the project site when requested or required.
- Optimal candidates may qualify for relocation assistance, but conditions may apply
Interested?
Contact Us to Apply!
Submit resumes / CVs via email to:
Brandon Shue, Principal – Triad Consulting Solutions LLC
(P): 706-998-2740
(E): info@triadconsultingsolutions.com