Job Description
Job Description
Position Summary
The Validation Engineer is responsible for assisting in the development, execution and approval of all validation programs and lifecycle documentation, e.g. SOPs, Change Controls, CAPAs, Deviations, ensuring compliance with in-house specifications, standards and procedures and implementing industry best practices. This individual organizes validation activities to ensure completion of projects per schedule requirements.
Duties and Responsibilities
- Participate in the creation of Design Specifications, User Requirements and Functional Specification Requirements
- Perform installation, operational and performance qualification testing of equipment, including development of protocols, execution and report writing
- Represent the validation department in multi-disciplinary teams focused on production and laboratory equipment and activities (commissioning, validation and computerized system validation)
- Perform investigations and implement corrective actions related to CAPAs and deviations
- Coordinate the investigation, impact assessment and resolution for all deviated equipment or processes discovered upon validation or re-validation
- Provide technical assessments on change controls, deviations and investigations
- Communicate with clients and across departments to provide understanding of validation activities
- Support process development activities
- Perform factory and site acceptance testing of equipment, including development of protocols, execution and report writing
- Create and manage metrics to support trending and management review
- Perform temperature mapping, equipment, steam sterilization and cleaning validation
- Manage contractors performing equipment and system qualifications
- Support the execution of engineering projects
- Develop competencies in core process technologies and maintain knowledge of equipment and manufacturing technology changes
- Support continuous improvement projects and activities
- Work with subject matter experts (SME) to implement and/optimize key validation and quality initiatives
- Other duties as assigned
Regulatory Responsibilities
- Conduct business in a responsible manner that complies with all state, OSHA and HIPAA regulations
- Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements
Supervisory Responsibilities
- N/A
Experience
- Three (3) to five (5) years engineering experience
- One (1) to three (3) years working in a regulated industry
Education
- Bachelor’s degree in mechanical engineering or related science degree
Knowledge, Skills & Abilities
- Thorough knowledge of global regulatory requirements for validation, including Electronic Records, Electronic Signatures (Part 11 and Annex 11) & current GAMP5 guidelines
- Functional and teachable knowledge of the System Lifecycle Management process
- Hands on mechanical skills
- Ability to create and follow written directions, complete protocols and reports
- Ability to work independently
- Strong technical documentation skills
- Broad knowledge of engineering processes
- Knowledge of common materials, engineering methods, process controls and manufacturing systems
- Proficient with data analysis, statistics and applied mathematics
- Knowledge of design techniques, principles, tools and instruments involved in the production and use of precision technical plans, blueprints, drawings, and models
- Excellent written and verbal communications skills
- Computer skills including Microsoft Office (Excel, Word, Outlook), Visio or other related software
Physical Requirements
- Use of standard office equipment with or without reasonable accommodation.
- Visual acuity
- Fine and gross motor skills to manipulate tools and equipment
- Ability to remain stationary for prolonged periods of time, lift up to 50lbs., as required
- Ability to meet gowning requirements