Company Overview: LinHR‘ Client is a leading global tier 1 auto parts supplier, celebrated for its innovation and excellence in the automotive industry. With two major Engineering sites in the USA—located in Moraine, OH, and Brighton, MI—and a combined team of approximately 150 employees, we are committed to driving technological progress and nurturing a vibrant, collaborative work environment.
Position Summary: We are seeking seeking a Validation Engineer who is responsible for planning, executing, and documenting validation activities for products and systems to ensure compliance with internal requirements and external regulatory or customer standards. This role develops validation protocols, conducts tests, analyzes results, and partners with engineering, quality, and operations to maintain validated states and support audits.
KEY RESPONSIBILITIES
- Establish validation and qualification criteria for products and systems based on specifications and regulatory requirements.
- Develop, review, and execute validation master plans and protocols (for example DVPRs, test plans, and traceability).
- Create and run tests to evaluate system performance, capability, and repeatability against approved protocols.
- Oversee calibration, verification, and maintenance of instruments and equipment used in validation activities.
- Analyze test data using appropriate statistical methods and summarize results in validation reports with clear conclusions and recommendations.
- Identify deviations, non-conformances, and risks; lead or support root cause investigations and implementation of corrective and preventive actions (CAPA).
- Maintain validation documentation including protocols, reports, risk assessments, traceability matrices, and activity logs in accordance with quality system requirements.
- Ensure systems remain in a validated state through periodic review, revalidation, and change control support.
- Collaborate with engineering, quality, manufacturing, IT, and suppliers during design, commissioning, and qualification of new or modified equipment and processes.
- Support internal and external audits or inspections by providing validation documentation and subjectmatter expertise.
- Train or mentor technicians and junior team members on validation procedures, test methods, and documentation practices as needed.
- Ensure validation activities comply with applicable regulations and standards (for example ISO 9001 and IATF 16949, and relevant product standards).
REQUIREMENT QUALIFICATIONS:
- Bachelor’s degree in Mechanical, Electrical, Chemical, Biomedical, or related Engineering or a closely related scientific field.
- Experience in validation, test, quality, or process engineering in a manufacturing or laboratory environment (internships or coops for entry level).
- Strong understanding of manufacturing processes, quality systems, and applicable safety or regulatory requirements.
- Ability to develop and execute validation protocols, analyze technical data, and write clear technical reports.
- Knowledge of statistical analysis tools or software (for example, MATLAB, Minitab, or similar).
- Excellent attention to detail, organizational skills, and ability to manage multiple validation activities and deadlines.
- Effective communication and teamwork skills to work across engineering, quality, and operations teams.
PREFERRED QUALIFICATIONS:
- Experience in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or automotive safety systems.
- Familiarity with LabVIEW, Python, or other testing/analysis applications.
- Working knowledge of relevant standards and regulations (for example ISO 9001, and automotive‑specific standards).
- Experience with risk management tools (FMEA, risk matrices) and structured problem‑solving methodologies such as Six Sigma or Lean.
- Project management capability, including planning validation activities, coordinating cross‑functional resources, and tracking progress.
TRAVEL REQUIRED (%):
>50% travel to meet customers and suppliers with day travel to the various manufacturing facilities as required.
LANGUAGE SKILLS:
Mastery of the English language and ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS:
- Ability to calculate figures and amounts such as discounts, interest, commissions proportions, percentages, area, circumference, and volume.
- Ability to apply concepts of basic algebra and geometry.
COMPUTER SKILLS:
Ability to use and understand Windows Office Suite (Word, Excel, PowerPoint) and SharePoint, Microsoft (email). This is additional to the computer skill requirements as stated in the requirement qualifications.
REASONING ABILITY:
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
- Ability to read and understand engineering prints/drawings. Good level of analytical skills and interpersonal skills. Ability to work on a team. Ability to guide the efforts of support personnel. Good team building skills.
PHYSICAL DEMANDS:
- The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to walk and to sit; use hands to manipulate objects, tools, or controls; reach with hands and arms.
- The employee is occasionally required to stand, stoop, kneel, crouch, or crawl; and to talk and hear. The employee must occasionally lift up to 30 pounds. Specific vision abilities include close vision, color vision, peripheral vision, depth perception and the ability to focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
What We Offer:
- Competitive salary 90K to 110K and performance-based incentives.
- Comprehensive benefits package, including vacation, medical, dental, vision, Pcard, Travel card, 401(k) with company match.
- A dynamic, inclusive work environment where your ability to unite people and execute solutions will directly impact business success.
LinHR is committed to providing accommodations for people with disabilities. If you require an accommodation, we will work with you to meet your needs. Accommodation will be provided in all parts of the hiring process as required under LinHR's Employment Accommodation Policy. Applicants need to make their needs known in advance.
LinHR is an equal opportunity employer seeking to live its values in all we do. We are committed to taking proactive steps to provide and create opportunities for historically marginalized groups. We seek applicants who will strengthen our commitment to diversity, equality, and inclusion. We strongly encourage qualified candidates from Indigenous, Black and other racialized persons, 2SLGBTQI+ people, individuals with disabilities, and other members of marginalized communities to consider working with and for LinHR. We recognize that structural barriers shape experiences and job qualifications, and therefore we seek to use employment equity to differentiate between candidates who meet the required qualifications. We encourage people to apply even if they feel that the position would be a stretch.
LinHR uses AI-assisted tools only to support screening and efficiency, never to make final decisions. All hiring decisions are made by human professionals, and candidates may request human review at any time.
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