Senior Validation Engineer
Location: Pittsfield, ME - Option to be remote.
The Senior Validation Engineer will support all manufacturing sites and lead the optimization of existing processes. This leader will ensure that processes are properly validated and documented and bring their experience using Good Manufacturing Processes (GMP) for FDA regulated products.
Duties and Responsibilites:
- Responsible for compliance with applicable Corporate & Site policies and procedures to maintain a Validation Master Plan for the sites products, supporting audits and any gap remediation required for Process Validation.
- Initiates and completes technical activities leading to new or improved process validations to meet the company’s strategic goals.
- Gather data, create reports and present findings and trends while making recommendations based on results.
- Understands engineering principles theories, concepts, practices and techniques.
- Interfaces with internal business areas, multiple locations leading validation continuous improvement initiatives.
- Responsible for training programs to improve the quality of documentation and process outcomes for current and future programs.
- Cultivates internal and external network of resources to deliver results.
- Leadership over project teams, determining goals and objectives for the projects with a strong technical contributor to develop and fully validate the process.
- Process Validation, root cause analysis, problem solving.
- Works on Problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Mentors employees by sharing technical expertise and providing feedback and guidance.
Education and Experience:
- Bachelor’s degree with an advanced degree preferred in Engineering (mechanical, manufacturing, biomedical, etc)
- 6+ years of related work experience with a strong understanding of manufacturing processes and Process Development and Validations or an equivalent combination of education and work experience.
- Experience working in a regulated manufacturing environment with a strong preference in FDA and ISO 13485.
- Technical Business Knowledge: wide application of technical principles, practices and procedures.
- Experienced in design controls, GMP, statistical analysis, risk analysis and cross group dependencies and relationships.
- Cognitive and Critical Thinking Skills
Location: Our Flagship Operation is in Guildford, ME with 2 production plants in Pittsfield, ME with a sales office in Falmouth, ME. Depending on role, we will consider candidates working remote with occasional travel (25%) to these locations.
Hardwood | Puritan is An Equal Opportunity/Affirmative Action Employer. All qualified applicants and employees for hiring, placement and advancement will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or military status, age, or any other federally protected class.
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