TITLE: SYSTEMS ENGINEER/VALIDATION ENGINEER
REPORTS TO: Systems Team Leader
Under general supervision, designs, plans, schedules, and assists in execution of validation work. Develops project documentation that accurately and effectively supports the BMS Life Sciences applications, provides evidence that the BMS meets project requirements, specifications, and applicable regulatory requirements.
Assists in defining scope of project in coordination with sales, installation operations and customer. May be required to train (or assist with) individuals executing validation protocols as required. Understands the responsibility of cost control, and quality control. Acts as main liaison to customer representatives of Quality Assurance, Building Owner, Facilities/Plant Engineering and Validation and other related departments.
- Authors project documents as needed to satisfy project requirements.
- Authors Test Procedures, and summary reports to satisfy project scope requirements.
- Authors Customer Standard Operating Procedures (SOPs) to satisfy project requirements.
- Obtains protocol approval from customer representatives.
- Routes (expedites as needed) documents for signature as required.
- Performs validation document peer reviews prior to customer submittal to ensure technical accuracy and compliance to customer requirements.
- Interprets applicable regulatory requirements and ensure that project deliverables meet these and specific customer requirements.
- Provides consultative services to internal and external customers.
- Develops project execution plans and ensures plans are executed.
- Coordinates with Project Lead to ensure cGMP requirements are met while ensuring project schedules and cost estimates are maintained.
- Assists Project Lead in resolving project delays, changes and contractor disruptions.
- Attends customer meetings as required in order to gain knowledge of project requirements and scope.
- Utilizes standard tools for development work whenever possible.
- Executes scope discovery tools (e.g., Val. Scope Checklist, BMS Platform Questionnaire) when requested.
- Mentors Technical Writers and Validation Engineers as required.
Bachelors degree in a technical capacity (ME, EE, or other equivalent technical field). A minimum of four years experience in an Engineering capacity, preferably in BMS/HVAC controls.
Good understanding of Pharmaceutical processes and plant design, cGMP principles, documentation practices and validation requirements. Strong knowledge of engineering fundamentals and HVAC concepts and operations. An understanding of project design, programming, job startup & commissioning, troubleshooting, and project financial reports. Strong oral and written communication skills, personal computer skills, are required. Project Management skills desired but not required. Strong organizational skills are required. Ability to mentor and coach others in the organization as needed.