Process Validation Engineer - Katalyst Healthcares & Life Sciences
Waltham, MA 02451
About the Job
Responsibilities:
- Assists in optimization of current processes, and development of new processes in support of R&D, Manufacturing and Product Development.
- Provides support and guidance on validation activities related to manufacturing/test equipment and processes.
- The process engineer will conduct a gap analysis of existing sealing equipment and Establish/Document a validated test method and qualified sealing equipment to ensure reliable seal strength measurements in compliance with ISO 11607 and ASTM standards.
- Bachelor's degree in engineering or equivalent work experience.
Minimum of 3 (three) years direct process engineering experience in medical device industry. Good analytical and problem-solving skills. - Excellent written and verbal communication skills with good presentation and technical writing skills.
- Collaborative attitude with the ability to work well in a team environment.
- Strong engineering, design, and analysis skills.
- Working knowledge of tooling and manufacturing processes.
- Experience with medical devices from concept to commercialization.
- Experience qualifying sealing equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate its performance within the defined operating ranges.
- Understanding of FDA Quality Systems Regulations.
- Accurate Ability to perform work accurately and thoroughly.
- Communication (Written /Oral) Ability to communicate effectively in written and oral form.
- Excellent report writing skills essential.
- Problem Solving Ability to find a solution or deal proactively with work related problems.
- Interpersonal Ability to develop and sustain positive relationships with internal as well as external customers.
- Advanced computer skills including MS Office applications (Word/Excel) and Minitab statistical analysis software are required.
- Knowledge of statistical techniques and sampling for process validation and process monitoring desired.
- Experience with Agile PLM or other documentation management system desired.
Source : Katalyst Healthcares & Life Sciences
