Validation Engineer I

Location: Rocky Mount, North Carolina
Posted On: 9/8/2017
Job Code: 8583
Job Description
Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (It may be helpful to complete this section after you have finished the other sections of the document.
The Associate Quality Engineer-Compliance will be responsible for performing thorough, detailed and timely tasks to obtain and maintain the validated state of networked and standalone quality laboratory computer systems. Responsibilities include assessing changes to specifications and regulatory requirements, determining the impact of changes with regard to product and process quality, and implementing appropriate measures to ensure compliance. The job plays a key role throughout the computer system lifecycle, from validation of new systems through qualification of changes for existing systems, to assure that all critical systems remain in a validated state.

In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.

Below is a representation of the kind of responsibilities expected. Other duties not included below are typically required for the job.

1. Ensures controlled access to all validated software systems including LIMS and NuGenesis.
2. Provides administrative duties for quality laboratory computer systems; ensures efficient trouble-free operation of systems; trains and provides support for end users; installs associated equipment (barcode readers, printers, etc.); documents and troubleshoots system issues.
3. Assures that all data and information is gathered and recorded in accordance with cGMP requirements.
4. Supports the configuration and implementation of new standalone and networked quality laboratory computer systems.
5. Analyzes data to verify that acceptance criteria for validation protocols are met and writes deviation reports as required upon failures to meet protocol acceptance criteria.
6. Determine root cause and implement appropriate CAPAs.
7. Responds to inquiries from management, employees and regulatory agencies, and communicates status on a frequent basis.
8. Assists in planning, directing, and documenting user acceptance testing.
9. Maintains close communication with stakeholders and team members to keep subject parties apprised of quality laboratory computer system incidents/resolutions, project validation status, and other relevant issues.
10. Verifies that backup, archival, and retrieval of electronic cGMP data is performed successfully.
11. Manages site change control systems for quality laboratory computer systems.
12. Performs follow-up activities to coordinate the completion of corrective actions and preventive actions.
13. Works independently or with others to validate quality laboratory computer systems.
14. Ensures project deadlines and performance standards are met, and communicates status accordingly.
15. Revises quality system SOPs.

Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
Quality Engineer reports to the Department Manager. This position requires interaction with several departments throughout the facility.

Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).

• Bachelor’s degree in Biology or related subject with 2-3 years experience in the FDA regulated industry
• Ability to effectively collaborate with others to achieve team goals and expectations.
• Must be familiar with cGMP.
• Must be able to work independently and in a team environment.
• Prior experience with Environmental Monitoring and/or Finished Product testing for microbiology.
• Prior trending experience preferred.
• Prior experience with implementing or validating LIMS preferred.

Indicate the technical skills required and/or preferred, as applicable.
• Must be familiar with laboratory systems such as LIMs, TrackWise.

Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc. Please include any hazardous materials or non-standard working environment the contractor will have exposure to which may require additional medical testing and/or apparatus fitting for OSHA compliance.
• Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 5 pounds per activity 4 times per shift, work around moving equipment, work with biological materials.
• Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.
Position Comments visible to MSP and Supplier: 3 years of experience preferred.
Category:IT  code:new
Job Requirements
MS Access, Compliance, Management

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Contact Details
Ajaykrishnan Ks