Sr Validation Enginee

Position Objective
- Uses professional concepts and company's policies and procedures to test and assure compliance of the company's lab equipment, processes, network and PC based automation systems.

Essential Functions
- Test, troubleshoot, and qualify equipment and PC based laboratory automation systems used in a FDA / EMA regulated environment.

- Test, troubleshoot, and qualify Information Technology infrastructure and network based applications used in a FDA / EMA regulated environment.

- Test, troubleshoot, and qualify spreadsheets used for data analysis and collection used in a FDA / EMA regulated environment.

- Participate / initiate change controls for equipment, PC based laboratory automation, IT infrastructure, network applications and spreadsheets used in a FDA / EMA regulated environment.

- Act as a liaison with application developers, IT infrastructure and database administrators in application and system related activities for FDA / EMA regulated systems.

- Act as a team member in the selection, design, and implementation of new or updated IT infrastructure, application programs, databases, laboratory equipment and automation systems, and/or other hardware.

- Actively contribute to long-term planning for system improvements. Assist with planning, implementation, testing, and maintenance of Business Continuity procedures and systems. Update and review detailed system documentation, procedures, policies and standards in accordance with regulatory guidelines.

- Works with the Validation Manager / Director to develop life cycle documentation and validation standards.

- Acts as a liaison with validation contractors in equipment, application and system related activities for FDA / EMA regulated systems.

- May perform other related duties as required and/or assigned.


Nature and Scope:

- Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors. Exercises judgment within defined procedures and policies to determine appropriate action.

- Acts as advisor to unit or subunits, becomes actively involved as required to meet schedules or resolve problems.

- Frequently interacts with outside customers, and functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc.

- Provides immediate supervision or assigns tasks to a unit or group of employees. Provides general or direct supervision to exempt employees and/or skilled nonexempt employees.

- Has expert knowledge of regulatory requirements in specific or broad areas.

- Acts as technical lead for a development project and interfaces with other departments to coordinate improvements.


Education:

BS degree in Engineering or Computer Science.
Experience:

A minimum of 5 years experience in Validation in a FDA / EMA regulated environment, 1-2 years of project management experience.
Contacts:

Interacts at all levels of the organization with internal as well as external customers. Normally self sufficient in all aspects.
Working Conditions:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing this job, specifically during audits/inspections, the employee will be exposed to moving mechanical equipment, harsh and/or toxic chemicals and biologicals, low levels of radiation and extreme cold (-70C). Noise level in some areas can exceed 100 decibels. Overtime may be required.