Top 8 Quality engineer medical device Jobs in Lexington, Ky

CQV Engineer I
IPS-Integrated Project Services —Lexington, KY
- Full-time
- Construction site
- Ability to walk for extended periods
- Bachelor of Science
Sr. Validation Engineer
Kindeva Drug Delivery Careers —Lexington, KY
- Full-time
- 5 years
- Engineering
- Master's degree
Quick Apply
CQV Engineer III
IPS-Integrated Project Services —Lexington, KY
- Full-time
- Construction site
- Ability to walk for extended periods
- 5 years
Engineer for Corporate Technical Services
East Kentucky Power Cooperative —Winchester, KY
- Hybrid work
- Customer service
- Engineering
- No experience needed
- Health insurance
- Dental insurance
CQV Project Manager
IPS-Integrated Project Services —Lexington, KY
- Full-time
- 7 years
- Construction site
- Ability to walk for extended periods
Sr. Manager, Validation Engineer
Kindeva Drug Delivery Careers —Lexington, KY
- Full-time
- Engineering
- Office
- 3 years
Quick Apply
EMC Engineering Team Lead
Intertek —Lexington, KY
- Full-time
- Customer service
- Pass drug screening
- Data analysis skills
- Health insurance
- Dental insurance
Quick Apply

More jobs to discover

Find similar jobs that you might be interested in.

Sr. Validation Engineer
Kindeva Drug Delivery Careers —Lexington, KY
Bachelor’s degree in engineering, life sciences, or a related technical field. Your expertise in cGMP, risk-based validation, and technical writing will…
Quick Apply
Sr. Mechanical Engineer
Xerox —Lexington, KY
This role ensures product quality, continuity of supply, and cost-effective manufacturing by driving disciplined testing, cross-functional collaboration, risk-…
$109,818 - $192,000 a year

Show more similar jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Director of Service
React Health Holdings, LLC —Dublin, OH
Serve as the operational owner of post-market product performance monitoring, providing leadership in service trending, field reliability analysis, and…
$125,000 - $150,000 a year
Quick Apply
Sr Device Assembly Engineer
Amgen —New Albany, OH
The engineer serves as a technical subject matter expert, partnering across Device Engineering, equipment system owners, Combination Products Organization,…
$115,494.60 - $156,257.40 a year

Show more jobs in cities nearby

I want to receive the latest job alert for quality engineer medical device in lexington, ky

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality engineer medical device jobs near lexington, ky

Engineer jobs in Lexington, KY

Project Manager jobs in Lexington, KY

Engineering Team Leader jobs in Huntington Beach, CA

Worship Leader jobs in Wisconsin

Engineering Team Leader jobs in Garden City, ID

Engineering Team Leader jobs in Chagrin Falls, OH

Engineering Team Leader jobs in Randallstown, MD

No Experience Necessary Industrial Engineering jobs in Texas

Ai Engineer jobs in Philadelphia, PA

Systems Engineer jobs in Houston, TX

Electrical Engineer jobs in Albuquerque, NM

Data Center Engineer jobs in Seattle, WA

Engineer jobs in Lynchburg, VA

Senior Developer jobs in Magnolia, TX

Senior Developer jobs in Fort Irwin, CA

Senior Developer jobs in Seneca, SC

Part Time Senior jobs in Rhode Island

Senior Developer jobs in Birmingham, AL

Project Manager jobs in Salt Lake City, UT

Project Manager jobs in Chapel Hill, NC

CQV Engineer I

IPS-Integrated Project Services -
Lexington, KY

Apply Now

Job Details

Full-time

Qualifications

Bachelor's degree in engineering

Full Job Description

Job Description:

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer I to join our team at our project site near Lexington, Kentucky.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.

Additional Responsibilities

Write C/Q/V documents following established standards and templates, including but not limited to the following:
- Commissioning Forms
- C/Q/V Protocols and Summary Reports
- Standard Operating Procedures
- Impact Assessments
- Specifications (URS/FRS/DDS)
- FATS/SATs
Perform field/site activities, including, but not limited to, the following:
- Attend and witness FATs and SATs as a representative of IPS clients.
- Execution of commissioning forms and witnessing of vendor start-up and testing.
- Execution of C/Q/V protocols.
- Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
- Compile data and prepare reports for completed C/Q/V activities, including ETOPs, protocol data packages, etc.
- Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
- Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management of project status and issues, as requested.

Qualifications & Requirements:

Bachelor of Science in Engineering.
0-2 years of relevant experience.
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or
QA.

Preferred Qualifications

Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.

Physical Demands

Must be able to: stand, sit, and walk for prolonged periods, stoop, kneel, crouch, and crawl as required.
Must be able to lift and move objects weighing up to 50 pounds and climb ladders as necessary.

Work Environment

Can work in both indoor and outdoor environments, which may include exposure to varying working conditions.
Can adhere to strict cleanroom gowning protocols.

Travel

This position will have up to 100% travel, or as required by the assigned project.
Position may be assigned to the client site for an extended period of time.
Overnight travel or staying in the city of the Client’s location is possible, depending on the assignment.
Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
Must have access to reliable transportation.

Safety

This position is a safety-sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.

All interviews are conducted either in person or virtually, with video required.

About Us:

IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.

Specialties

Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.

All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

#LI-EM1

Apply Now

Refine Your Search

quality engineer medical device jobs in lexington, ky

CQV Engineer I

Sr. Validation Engineer

CQV Engineer III

Engineer for Corporate Technical Services

CQV Project Manager

Sr. Manager, Validation Engineer

EMC Engineering Team Lead

More jobs to discover

Explore jobs in cities nearby

I want to receive the latest job alert for quality engineer medical device in lexington, ky

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected