Position Summary:
This individual will work in a dynamic team-oriented environment and has primary responsibility for defining, implementing and maintaining validation for manufacturing processes and systems. As a Sr Validation Engineer, you will have a strong process development or process engineering background and is able to work independently requiring minimal direction.
Additionally, this person will partner cross-functionally and cross-site with R&D, Quality, Facilities, Production, and other engineering groups to lead validation efforts, collaborate in developing validation strategies, and execute validation deliverables.
Position Responsibilities:
- Represent the Consumable Validation group in a cross functional project teams, ensuring validation requirements and deliverables are communicated to the teams.
- Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans.
- In collaboration with end users, process owners, Quality Engineers and other team members, develop validation protocols and oversee execution of IQ, OQ, PQ for manufacturing processes and systems.
- Lead investigations or troubleshooting discrepancies/deviation encountered during commissioning and qualification.
- Write reports summarizing results and statistics for all equipment and process validation projects.
- Be accountable for timely completion of all validation deliverables in accordance with project timelines.
- Learn and understand the applicable technology and engage in technical discussions.
- Provide consultation to other departments performing validation activities.
- Provide input for creation of requirements documents.
- Actively participate in creation of risk management documents such as pFMEA for systems and processes.
- Participate as required in regulatory inspections/internal audits and develop strategies for key validation topics.
- Perform job function in compliance with the internal procedures and applicable external regulations and standards, e.g. FDA QSR, ISO-13485.
- Initiate and execute controlled document change requests.
- Execute other related tasks assigned by the supervisor.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
- Excellent interpersonal and written skills; highly effective communication, facilitation, negotiation and teamwork skills are required.
- Able to work in manufacturing environment where there might be possible exposure to loud noise.
- Able to identify components with different colors (using visual).
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
- A minimum of 5 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech).
- Knowledge and working application of FDA and cGMP requirements.
- Intermediate knowledge and working application of validation principles and guidelines and industry practice, FMEA, and Risk Management.
- Knowledge and application of statistical techniques as a decision-making tool and practical experience in use of statistical analysis software JMP highly desirable.
- Proficient knowledge and working application of standard operating procedures, as well as process and system validation principles for regulated industries including: FDA cGMP; ISO 13485, ISO 14971, IVDD, FMEA, Risk Analysis and Design Controls and relevant regulations and requirements.
- Demonstrated ability to accomplish goals in collaboration with cross-functional teams.
- Experience with a high volume, consumable production process highly desired.
- Experience with product development processes and project management is a plus
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired
- Computer competency in MS Office.
- Adaptable to fast-paced, dynamic work environment with ability to manage projects methodically.
- Familiar with the ALCOA concept.
- Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring.
- Demonstrated analytical problem-solving skills in self-directed manner and must be able to work on problems of a complex scope.
