Pharmaceutical Process Engineer Jobs in Michigan

• Work on cutting-edge automotive ride control technologies
• Collaborative engineering environment
• Opportunity to contribute to next-generation mobility solutions

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.

• 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).

• 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, 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.

• 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.

Less than 5% travel to meet customers and suppliers with day travel to various technical centers and manufacturing facilities as required.

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.

Ability to apply concepts of probability and statistics, calculus, differential equations, linear algebra, and trigonometry as appropriate for data analysis, reporting and test development.

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.

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.

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.

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.