Your Key Responsibilities:
Build relationships to become a resource for process improvement, validation strategies, and technologies.
Develop, implement, or review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Develop or review of validation documents including user requirements, functional specifications, risk assessment, design description, and traceability matrices.
Coordinate with internal and external stakeholders to prepare validation designs and establish uniform specifications for processes and production equipment.
Assist in the evaluation of out-of-specification results and associated corrective actions.
Apply validation principles and requirements to process validation, equipment qualification, building, and facility qualification, test method validation, and/or cleaning validation systems.
Oversee validation activities of contractors and other employees.
Responsible for reviewing GMP documentation to support the validation effort including calibration, training, and preventive maintenance programs.
Supports programs that may affect the validated state which includes work instruction development, change control, and risk analysis.
Formulates and recommends validation guidelines, activities, and timelines in accordance with project objectives.
Delivers and presents technical and/or training presentations to management, employees, suppliers and contractors.
Actively pursues and enhances validation expertise.
Certification of those developing and executing validation activities.
What are we looking for?
BS in mechanical or electrical engineering or degree associated with certain validations (i.e. chemistry, physics)
Certification/training through ASQ, AAMI, CfPIE, or equivalent.
Minimum of 5 years experience in manufacturing environment or equivalent preferred.
Basic Microsoft Office, MS Project, Adobe Acrobat
Key Competencies needed for this position
Able to generate and explain extremely detailed proposals, guidelines, and procedures.
Analyze and resolve complex process development issues of broad scope using independent judgment.
Observe and correct minute inconsistencies in the printed word, product appearance, etc.
Excellent analytical skills.
Excellent interpersonal communication and managerial skills.
Effective participant on multi-disciplinary teams.
Well-organized and detail-oriented.
Strong verbal and written communication skills.Excellent communication skills, both oral and written, required
Strong working knowledge with word processing and computer database programs including Microsoft Office Suite (Word, Excel, PowerPoint and Access)
Demonstrated ability to critically evaluate a process and determine the key components of that process as well as the issues that are constraining that process
Work From Home: No
Travel Percentage: None