Validation Engineer II

Top Tool Company; Lowell (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in manufacturing solutions for medical devices seeks a Process Validation Engineer. This role involves writing and analyzing validation activities, supporting quality systems, and collaborating with multiple teams. Candidates should hold a relevant degree and have experience in validation studies, with a strong emphasis on compliance and teamwork.

Benefits

Healthcare and well-being programs

Paid Time Off

401(k) retirement savings with company match

Training and career development

Qualifications

• 2-5 years of relevant experience in validation studies.
• Understanding of cGMP requirements for validation documentation.
• Experience with regulatory agency inspections.

Responsibilities

• Provide technical input to validation activities.
• Support process validation Quality Systems.
• Participate in regulatory agency inspections for Process Validation.

Skills

Collaboration

Problem-Solving

Troubleshooting

Education

Bachelor’s degree in Chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering/Chemistry/Biochemistry

Job description

Current job opportunities are posted here as they become available.

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!

Position Summary:

This position is responsible for writing, implementing, analyzing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. Will include developing and assessing following the Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.

Key Responsibilities:

• Provide technical input to validation activities
• Support process validation Quality Systems
• Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices
• Participate in regulatory agency inspections for Process Validation
• Serve as one of the main points of contact in communication to customers whose equipment and processes are being validated
• Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities
• Complies with company, quality and safety standards, policies, and procedures.
• Other duties as assigned.

Must Have:

• Bachelor’s degree in Chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering/Chemistry/Biochemistry, or related field with 2-5 years of relevant experience
• Experience authoring and completing validation studies.
• Understanding of cGMP requirements for validation documentation.
• Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
• Experience authoring and building process validation studies for commercial GMP manufacturing processes
• Experience troubleshooting/problem-solving and risk assessment/mitigation
• Working knowledge of the science and technology for the major unmit operations associated with manufacturing operation is considered a plus.
• Must be able to read, write and speak English

Salary Range: $80,000-$100,000

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.