Validation Engineer

Associate Validation Engineer

Status: Full Time Employee

Overview: The validation associate will work closely with members of the senior validation staff to ensure company goals and objectives are met. This position is responsible for executing a variety of validation studies, including performance qualifications and/or re-qualifications of manufacturing and laboratory equipment or processes. Additionally, the Validation Associate will:

• Assist with writing and executing applicable validation protocols associated with the given project.
• Author relevant acceptance reports for the respective protocols.
• Provide timely and accurate updates to the respective project leader / project team with regards to validation activities.
• Once validation effort(s) are complete for given equipment or process, ensure applicable SOP(s) are updated and reflect results stated in approved acceptance report(s).
• Provide validation support to project teams involved in facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects, etc.
• Through education and experience possess a working knowledge of the operation of equipment and systems. This includes, but is not limited to, equipment and systems such as mix tanks, autoclaves, vial/syringe fillers, HVAC systems, aseptic processing areas, etc.
• Utilize excellent communication skills, including the ability to organize and write detailed protocols and reports. This includes the ability to use Good Documentation Practices to document the validation of systems and equipment.
• Properly apply knowledge of current industry practices and cGMP requirements with regards to the validation of equipment and systems.
• Possess the interpersonal skills necessary to work with project team members from various disciplines. This includes Manufacturing, Quality Assurance, Engineering/Maintenance, and Quality Control.
• Work closely with user departments to schedule validation tasks in a manner which maximizes the efficiencies of the study, while having minimal impact on the routine operations of the user department.
• Other duties as assigned.

Qualifications:

• Minimum 6 months of related experience required. 1-2 years’ experience in a regulated industry desired.
• Pharmaceutical and FDA Regulated industry experience desired.
• Validation experience desired.
• Working knowledge of Microsoft Office applications required.

Education/Experience:

• Associates of Science in technical or scientific discipline required, or 3 years related experience in lieu of degree. Bachelor of Science desired.

Physical Requirements:

• Employee may be required to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.

Training:

• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
• Must successfully complete all material handling training/verification as part of ongoing training.