Process Validation Engineer I, II, III or Sr (Days 8am to 5pm)

LSI Solutions Inc • Victor, NY

9d • $75,000 - $120,000 • Onsite

About The Position

The Process Validation Engineer will develop and execute validations to ensure regulatory compliance to established internal and external standards related to released product or current production. The individual will support the writing of validation protocols and reports, along with the gathering and analysis of data.

Requirements

• A minimum of 0-3 years' validation experience is required, software validation a plus. An advanced degree in a biomedical, quality or validation related discipline may count 2 years towards experience.
• Bachelor’s Degree in an engineering, technical or manufacturing discipline.
• Maintains accurate and compliant documentation to meet company and regulatory expectations.
• Excellent Communication skills, both oral and written.
• Basic knowledge of MS Office, MS Project, Minitab Statistical Software
• Knowledge in validation and statistical tools such as Sampling Plans, Experimental Design and Optimization is desired.
• Knowledge of current and applicable GMP regulations is required. Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations.
• The ability to participate in complex and cross-functional projects, work in a highly matrixed organization, and effectively prioritize and manage multiple project workloads is required.

Nice To Haves

• Knowledge or experience with quality audits is preferred

Responsibilities

• Responsible for developing Master Validation Plans (MVP).
• Development and execution of protocols supporting the topics of Facility, Utility, and Cleanroom Qualification, Equipment Qualification, Process Validation, Cleaning Validation, and Test Validation.
• Work with appropriate disciplines to develop strategies to test and validate the performance and reliability of equipment and processes.
• Conduct qualification testing in accordance with internal protocols/procedures or external standards and regulatory requirements.
• Analyze validation test data to determine whether systems or processes have met validation criteria and support investigation into root cause of problems.
• Produce validation reports as required including statistical analysis, results analysis, observations, and conclusions.
• Oversee technicians performing validations.
• Responsible for understanding, communicating, and following current Good Manufacturing Practices (cGMP’s).
• Work with cross functional teams on projects relating to various validation topics to support medical device manufacturing.
• To maintain open and cooperative relationships with colleagues involved in other aspects of the process or operations in order to promote strong teamwork and cooperation across the company to meet organization requirements.
• Assist with internal/external Quality System Audits.
• Identify and implement improvements for existing processes (Corrective and Preventative Actions-CAPA).
• Support facility, utility and operations related non-conformance reports (NCRs); root cause and corrective actions with a goal towards reduction and prevention.
• Support and adhere to the Quality Policy and Quality System procedures.

Benefits

• Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts
• 15 Paid Holidays, PTO, Sick Time
• Medical, Vision and Dental effective first day of employment
• Employee Referral Bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees