Job Title: Validation Engineer I

Summary:

Provides direct quality support (e.g. compliance, regulatory assessment, validation) to the business unit, clients and corporate management. Performs quality functions to ensure accurate and timely completion for activities and projects of low complexity with routine decision making required.

Essential Functions:

1. Plans, organizes, executes and tracks multiple tasks of low to moderate complexity to ensure timely completion of deliverables related to key quality functions.

2. Analyzes data for routine validation and production documentation to determine acceptability, identifies deviations and make appropriate notification.

3. Approves routine validation and production documentation w/o deviations.

4. Prepares documents and reports; gain multidisciplinary consensus with some degree of independence.

5. Maintains and uses database systems.

6. Performs Good Manufacturing Practices (GMP) audits and quality engineering activities related to process improvement.

7. Prepares, retrieves and reviews documentation for customer and regulatory audits. Assists with presentation of data during customer and regulatory audits.

8. Assesses impact of changes of moderate complexity.

9. Prepares documents for records archival.

10. Assists with training in area of expertise.

11. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.

12. Complies with all job-related safety and other training requirements.

13. Performs other duties as assigned.

Education:

Bachelor’s degree in a physical or biological science or production related discipline is preferred.

Experience:

Two years of relevant experience in Life Science, Chemistry, Biology, Engineering, Biomedical, or IT is preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Effective time management and prioritization skills. Requires discretion and independent judgment. Highly effective verbal and written communication skills. Proficiency in Microsoft Suite (Word, Excel, PowerPoint). Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.

Proficient in performing activities within at least one Key Quality Function with minimum direction. Key Quality Functions include: Lab Services, Validation, Batch Disposition, Compliance, Document Management, Customer Relations, and Quality Engineering. Outstanding attention to detail and organizational skills. Selfstarter, mature, independent and dependable.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds and occasionally pushing or pulling more than 100 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job.

The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.