Validation Project Engineer

Validation Project Engineer I UPM Pharmaceuticals is an independent, highly experienced, and award-winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical's mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability.

Summary:

Assists in validation project work associated with cleaning, process, equipment, facility and utility qualifications to ensure compliance with current Good Manufacturing Practices and UPM's quality requirements. Pursues increased familiarity with equipment in order to comprehensively explain its function and design and assist in troubleshooting. Assists in the development of documentation such as validation protocols, change controls, SOPs, risk assessments, annual product reviews, etc. as needed.

Essential Duties and Responsibilities:

1. Assists in writing, executing, reviewing and summarizing Installation, Operation and Performance Qualifications (IQ/OQ/PQ) for new and existing equipment, systems and utilities under the direction of higher level Validation Engineers. 2. Perform requalification of equipment, systems and utilities as required. 3. Assists in the execution of cleaning and process validations under the direction of higher level Validation Engineers. 4. Identify deviations encountered during protocol execution, write deviation reports and help develop appropriate resolution. 5. Assist in developing, planning and executing Validation Project Plans. 6. Adhere to department and project deadlines, expectations and priorities while developing realistic goals for timely completion of projects. 7. Participate in evaluating and recommending new equipment or process changes. 8. Assess, evaluate and perform testing necessary to close out change controls in a timely manner. 9. Support process and cleaning validation as needed. 10. Other duties as may be assigned.

Education/Experience:

Bachelor's degree in a science/engineering related field and at least three years of pharmaceutical validation experience in a GMP environment, or equivalent combination of education and experience. 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.

Job Type:

Full-time Pay:

$1.00 - $2.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Life insurance Paid time off Referral program Relocation assistance Retirement plan Vision insurance

Work Location:

In person