Validation Engineer jobs in Kingsport, TN

Plans, writes, implements and reviews Computer Systems Validation protocols in a GMP environment. Ensure that all GxP computer-based systems are operating as intended and meet regulatory requirements. Assist with data integrity assessments, solutions and maintenance.Essential Duties and Responsibilites

• Write, review, and execute computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary reports).

• Perform Gap Analysis of SOPs and validation documentation for GMP, Part 11 compliant software systems.

• Submit Corrective Action Plan for addressing identified gaps.

• Assess computer systems according to data integrity guidelines. Identifies risks, recommend solutions, and perform routine tasks for systems including user reviews, backup/recovery tasks and disaster recovery testing.

• Responsible for overseeing, revisions and following computer system validation SOPs.

• Department subject matter expert for data integrity.

• Coordinate validation projects.

• Support change control activities for GMP Computer Systems.

• Knowledge of industry guidelines (ISPE, GAMP5, 21 CFR Part11).

• All other duties as may be assigned.

Knowledge Necessary to Perform the Job:

• Knowledge of IT SOPs.
• Knowledge of Computer Validation.
• Knowledge of Data Integrity.

Competency:
To perform the job successfully, an individual should demonstrate the following competencies:

• Problem Solving: Identifies problems and troubleshoots best way to resolve.
• Technical Skills: Knowledge of UPM software systems and computer validation.
• Oral Communication: Ability to verbally describe computer validation, data integrity and IT needs utilizing non-technical language both internally and externally.
• Written Communication: Writes clear and accurate documents.
• Ethics/Professionalism: Works with integrity and ethically maintains confidentiality. Projects a professional and courteous business demeanor.
• Organizational Support: Supports organization’s goals and values. Follows policies and procedures.
• Adaptability: Ability to deal with frequent changes to schedules, delays, or unexpected events.
• Attendance/Punctuality: Maintains regular and punctual attendance.
• Initiative: Preemptively identifies data integrity and computer validation issues. Evaluate and determine potential software systems around computer validation.
• Quality: Observes company quality policies and procedures.
• Safety and Security: Observes safety and security procedures.

Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or abilities required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Education/Experience: Bachelor’s degree – Information Technology, Chemical/Biological Science, Engineering, or a related technical field. A minimum of two years of CSV (Computer System Validation) on-the-job experience.
• Language Ability: Ability to read, analyze, and interpret GMP computer validation and data integrity guidelines. Ability to organize, document and control IT Documentation, and respond to inquiries from company staff and management.
• Math Ability: Ability to add, subtract, multiply, and divide. Basic mathematical skills are required.
• Reasoning Ability: Ability to determine priority of computer validation and data integrity tasks.
• Computer Skills: To perform this job successfully, an individual should have basic computer skills with knowledge of Word, Excel, Access, Outlook and ability to use internet tools. As well as the overall software of UPM.
• Work Environment and Physical Demands: The work environment characteristics and physical demands 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. The noise level in this work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand, walk, sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.
• Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

To apply, send resume and salary requirements to:
humanresources@upm-inc.com

Pay: $18.76 - $22.59 per hour

Schedule:

• 8 hour shift
• Day shift
• No weekends

Work Location: In person