Validation Engineer
Brighton, MI · On-site
Experience in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or automotive safety systems. * Familiarity with LabVIEW, Python, or other testing/analysis applications.
Validation Engineer
Brighton, MI · On-site
Experience in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or automotive safety systems. * Familiarity with LabVIEW, Python, or other testing/analysis applications.
Experience in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or automotive safety systems. * Familiarity with LabVIEW, Python, or other testing/analysis applications.
Experience in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or automotive safety systems. * Familiarity with LabVIEW, Python, or other testing/analysis applications.
Biotech information
What is biotech?
Biotech, the preferred shorthand for biotechnology, is a field of technology focused on the use of biology. The main focus of this field is the use of cellular and biomolecular processes to develop new products. While the modern use of the term focuses on medical research done in labs, biotechnology is considerably more expansive than most people realize. The three primary fields of focus are food, fuel, and medicine. For example, bread and cheese come from ancient biotechnology techniques. Whether your job as a biotechnologist focuses on developing a drug for a company or trying to generate electricity from plants, biotechnology has the potential to create significant advances in technology, and that's why so many universities and companies study it.
What are biotech jobs?
Biotech jobs are roles within the biotechnology industry, which combines biology, technology, and engineering to develop products and solutions for healthcare, agriculture, environmental management, and more. These positions can include research scientists, laboratory technicians, bioprocess engineers, quality assurance specialists, regulatory affairs managers, and clinical research associates. Professionals in biotech work on developing new drugs, therapies, medical devices, genetically modified organisms, and biofuels. The field is interdisciplinary and offers opportunities in both research and business settings.
What are the key skills and qualifications needed to thrive in a biotech role?
To thrive in a Biotech role, you need a solid background in biology, chemistry, or related sciences, often supported by a relevant degree and laboratory experience. Familiarity with laboratory techniques, data analysis software, and regulatory compliance systems is typically required. Strong problem-solving abilities, attention to detail, and effective teamwork set standout professionals apart in this field. These skills and qualities are crucial for driving innovation, ensuring data integrity, and meeting rigorous industry standards.
What are some common challenges faced by professionals working in the biotech industry?
Professionals in the biotech industry often face challenges such as keeping pace with rapid technological advancements and adapting to strict regulatory requirements. Additionally, project timelines can be unpredictable due to the complexity of biological systems and the need for rigorous testing and validation. Collaboration across multidisciplinary teams—including scientists, engineers, and regulatory specialists—is essential, which can require strong communication and project management skills. Navigating these challenges can be highly rewarding, as they often lead to innovative solutions and significant scientific breakthroughs.
What is the difference between Biotech vs Laboratory Technician?
| Aspect | Biotech | Laboratory Technician |
|---|---|---|
| Required Credentials | Bachelor's degree in biotech, biology, or related field; sometimes advanced degrees | Associate's or bachelor's degree in laboratory science or related field |
| Work Environment | Research labs, biotech companies, pharmaceutical firms | Hospitals, research labs, manufacturing facilities |
| Industry Usage | Biotech research, product development, clinical trials | Sample analysis, testing, quality control |
Biotech professionals typically hold higher degrees and work in research-focused environments, developing new products or therapies. Laboratory Technicians perform routine testing and analysis, often in clinical or manufacturing settings. Both roles are essential in the biotech industry but differ in scope, responsibilities, and required qualifications.
What are careers in biotech?
Careers in biotech include roles such as research scientists, lab technicians, quality assurance specialists, and regulatory affairs professionals. These jobs often require knowledge of biology, chemistry, and laboratory techniques, and may involve working in research labs, manufacturing facilities, or clinical settings.
More about Biotech jobs
What are popular job titles related to Biotech jobs in Howell, MI?
For Biotech jobs in Howell, MI, the most frequently searched job titles are:
What cities near Howell, MI are hiring for Biotech jobs?
Cities near Howell, MI with the most Biotech job openings:
Full-time
Re-posted 12 days ago
Job description
POSITION SUMMARY:
BWI Group is a premier chassis supplier that designs and manufactures brake and suspension systems for the global transportation market. BWI Group is 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.
JOB 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, nonconformances, 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 subject‑matter 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 co‑ops 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, EMC, 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 (%):
gt;25% travel to meet customers and suppliers with day travel to various technical centers and 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 apply concepts of probability and statistics, calculus, differential equations, linear algebra, and trigonometry as appropriate for data analysis, reporting and test development.
COMPUTER SKILLS:
Ability to use and understand Windows Office Suite (Word, Excel, PowerPoint, Outlook) and SharePoint. 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. Able to read and understand engineering prints/drawings. High level of analytical skills and interpersonal skills. Ability to work on a team. Ability to guide the efforts of support personnel. Good teambuilding 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.
For more information about BWI Group, please visit our website at www.bwigroup.com
Interested candidates, please send resume to careers@bwigroup.com and hr.us@bwigroup.com