Validation Engineer

The Planet Group; Indianapolis (IN); On-site; USD 75,000 - 90,000; Full time

Job summary

A leading company is seeking a Validation Engineer who will be responsible for developing Validation Plans and executing protocols throughout the validation lifecycle. The ideal candidate will have a bachelor's degree in engineering and experience in medical device manufacturing, specifically knowledgeable in regulatory requirements. This position offers a competitive salary with benefits including profit-sharing and bonuses based on performance.

Benefits

Great benefits

Profit-sharing opportunity

Qualifications

• 3-5 years' experience in Medical Device manufacturing preferred.
• Knowledge of ISO13485 and FDA regulations required.

Responsibilities

• Develop and author Validation Plans and protocols.
• Analyze data using statistical techniques and tools.
• Manage projects effectively while meeting schedules.

Skills

Validation experience

Process and equipment qualification

Statistical analysis

Documentation skills

Time management

Quality-oriented

Microsoft tools proficiency

Education

Bachelor’s degree in engineering

Job description

A Validation Engineer responsible forthe development/authoring Validation Plans (VP) and protocols for all phases of the validation lifecycle execution of test protocols and analysis of data using statistical techniques, tools and software.



Required:

• 3-5 years’ experience in Medical Device manufacturing is preferred


• Bachelor’s degree in engineering or engineering technology (Mechanical, Electrical, Biomedical)


• Knowledgeable on ISO13485, regulatory requirements, and FDA 21 CFR 820/GMP Medical Device Regulations


• Experience with different manufacturing processes, such as automated assembly lines, manual assembly processes, molding processes and packaging processes.

Skills and Responsibilities:

• Validation experience, process and equipment qualification (IQ, OQ, PQ), Test Methods & GR&R’s


• Process development/characterization experience


• Ability to analyze data through the use of statistical principals (e.g. process capability, normality test, GR&R, etc.) and statistical software (e.g. Minitab)


• Ability to compose professional and engineering documentation (e.g. protocols, engineering studies, reports, etc.)


• Ability to manage time and projects effectively while setting and meeting aggressive schedules


• Quality oriented individual with a focus on making data driven decisions


• Proficient with the use of Microsoft tools (Word, Excel, Project, Power Point, Visio)


• Ability to understand business, legal and regulatory requirements

Pay range:$75K - $90K.

Bonus:5-20% (company performance)

Great benefits and profit-sharing opportunity!



At The Planet Group, we connect Engineering experts with opportunities that match their skills, goals, and ambition. From fast-moving startups to global enterprises, we partner with top organizations across industries—giving you access to roles where your contributions make a difference. Explore flexible options including contract, direct hire, and contract-to-hire, all supported by a team that puts people first.





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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Staffing and Recruiting

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