Description
Location:
Andover, MA
Duration:
10 months+ (Possible extension or full time opportunity)
Description:
- Guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing.
- Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business.
- Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices
- Manufacturing software validation for medical devices within manufacturing environment.
- Guide and participate in bug testing, identification, and problem solving
- The Software Validation Engineer role will work closely with the Software Validation Management Team, other Q&R personnel and various project teams throughout the organization and across multiple sites.
- In this role, you will help provide regulatory guidance and perform project management duties to ensure all software validation projects and corresponding deliverables adhere to current regulations, industry standards, and Policies within the Monitoring Analytics & Therapeutic Care Business Group
Responsibilities:
- Participate in all CSV related projects within the MA&TC scope in support of achieving company objectives and ongoing commitment to quality
- Act as a project manager and lead CSV initiatives as assigned; perform activities to ensure CSV activities are performed, scheduled, planned, resourced and completed in accordance to established timelines
- Work closely with other Q&R members, IT personnel, system business owners, end users, etc. to provide adequate support and expertise; communicate effectively and clearly throughout all levels of the organization
- Guide stakeholders on software validation/quality relevance to establish suitable validation requirements and deliverables in accordance to FDA regulations and GAMP 5 principles
- Assist in generating and maintaining a complete and accurate inventory of all validated systems, including comprising components, validation deliverables and relevant meta data and system ownership information ensuring the validated state of each system is readily known at all times
- Perform and/or oversee CSV risk management activities; author/review risk assessments and perform risk mitigation activities as deemed appropriate
- Ensure Legacy systems are properly maintained and compliant based on current industry requirements and policies
- Measure and monitor CSV progress to senior management; generate reports and metrics as assigned
- Work with records personnel to ensure all validation deliverables are accessible and easily retrievable if needed during an internal/external quality audit
- Work with Document Control and Training Coordinators to assure concise CSV training materials are controlled, assigned, and maintained appropriately
Skills and Experience:
- Bachelor's degree and a minimum of 7 years of related CSV experience in the medical device or other FDA/ISO regulated industry
- Working knowledge of 21 CFR Part 11 and GAMP 5 is a must
- Understanding of appropriate global medical device regulations, requirements and standards, including of the following is a plus: FDA's 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6
- Government/regulatory-body Quality System auditing/inspection experience (ie, former FDA preferred)
- Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating exibility in prioritizing and completing tasks and communicating to a supervisor
- Attention to detail, organized and self-driven
- Solid interpersonal and communication skills
- Ability to communicate effectively both orally and in writing; smart technical writing skills a must
- Effective time management; able to balance multiple projects simultaneously
- Open to other's ideas and working collaboratively across functions and/or businesses throughout all levels of the organization
- Strong computer and technical writing skills
Experience:
- Minimum 8 years professional experience in the applicable role.
- Demonstrated capability and experience in role
Education:
- Bachelor's/Master's Degree in Engineering