Validation Engineer
Job
Actalent
Saint Paul, MN (In Person)
$95,680 Salary, Full-Time
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Job Description
Job Description:
The Validation Engineer will be responsible for preparing and executing commissioning, qualification, and validations for new processes, materials, equipment, cleaning, and computerized systems/software.Responsibilities:
Support validation activities in a cGMP regulated manufacturing environment. Prepare, review, and execute commissioning, qualification, and validation documents for processes, materials, equipment, cleaning, and computerized systems/software. Support Project Teams in GMP Impact Assessments, User Requirement Specifications, Traceability Matrices, Design Qualifications, and Risk Assessments. Handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management. Participate in and support validation projects within the pharmaceutical development and manufacturing areas. Conduct equipment qualification and requalification as part of the equipment lifecycle. Design and execute engineering (pre-validation) studies to support validation activities. Assist in troubleshooting of process issues, process characterization, and root cause investigations. Resolve deviations/non-conformances observed during execution of qualification and validation activities.Essential Skills:
3 - 5 years of validation experience in a regulated industry/GMP environment. Equipment validation experience. Experience in material qualifications, equipment validation, material-handling equipment, materials management, commissioning, and GMP environments. Proficiency in manufacturing processes, pharmaceutical design validation, risk assessment, validation verification, troubleshooting, equipment qualification, and equipment calibration.Additional Skills & Qualifications:
Bachelor's degree in Engineering or a relevant field or equivalent experience. Experience in equipment life cycle management, material qualification, and computerized system/software validation. Experience with water systems is desired but not required. Ability to apply sound engineering logic to solve complex problems, assess risks, and make decisions accordingly. Proficiency with Microsoft Office programs such as Word and Excel. Job Type & Location This is a Contract to Hire position based out of Saint Paul, MN. Pay and Benefits The pay range for this position is $40.00 - $52.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Saint Paul,MN.
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