An established and growing medical device manufacturer is seeking a highly motivated Engineering Technician or Validation Engineer to join its team. This company specializes in developing and producing pharmaceutical and medical device products that meet the highest quality and regulatory standards.
The organization fosters a collaborative, inquisitive, and process-driven culture, where employees are encouraged to ask questions, challenge assumptions, and drive continuous improvement. This is an exciting opportunity to gain hands-on experience in validation, manufacturing processes, and regulatory compliance while working closely with a dedicated and supportive team.
The Opportunity
As an Engineering Technician or Validation Engineer, you will play a critical role in supporting manufacturing operations, executing validation protocols, and ensuring compliance with industry regulations. You will work closely with engineering leadership to support key manufacturing processes and contribute to process improvements.
Key Responsibilities
Validation Execution: Conduct IQ/OQ/PQ validation studies for equipment, processes, and materials, ensuring compliance with regulatory standards.
Process & Manufacturing Support: Assist with formulation processes, lab work, and troubleshooting production equipment.
Technical Documentation: Develop and maintain validation protocols, final reports, and supporting documentation.
Regulatory Compliance & Continuous Improvement: Ensure adherence to ISO 13485, GMP, and FDA requirements while identifying process improvements.
Data Collection & Analysis: Monitor process performance using statistical tools and contribute to root cause analysis when needed.
Qualifications
Required:
Associate's or Bachelor's degree in Engineering, Life Sciences, or a related technical field.
1-5 years of experience in a regulated manufacturing environment (medical device, pharmaceutical, healthcare, or food manufacturing preferred).
Hands-on experience executing validation protocols, including technical writing of reports.
Knowledge of Good Manufacturing Practices (GMP) and FDA regulations.
Strong technical writing and communication skills.
Preferred:
Experience in formulation, lab work, or handling chemicals in a controlled environment.
Familiarity with ISO 13485 and its application in medical device manufacturing.
Proficiency in data collection, statistical analysis, and process troubleshooting.
Six Sigma Green Belt certification is a plus.
Who We're Looking For
The ideal candidate:
Thrives in a collaborative environment and values critical thinking and problem-solving.
Asks insightful questions to drive process improvements rather than following instructions without understanding the bigger picture.
Demonstrates accountability, integrity, and attention to detail, ensuring accurate reporting and data analysis.
Is open to growth opportunities, taking on new challenges within a dynamic team.
Why Apply?
Join an established and growing team in the medical device manufacturing industry.
Gain hands-on experience with key validation and manufacturing processes.
Work in a collaborative environment that values professional development and encourages innovation.
Apply Today
If you are a detail-oriented engineering professional with experience in validation and manufacturing support, we encourage you to apply. This is a great opportunity to contribute to a company making an impact in medical device innovation while growing your career in a regulated industry.