LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.

We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient.

POSITION TITLE: Process Validation Engineer I, II, III or Sr.

SHIFT HOURS: 8:00am to 5:00pm.

LOCATION: Onsite at LSI Solutions in Victor, NY.

SALARY RANGE: $75,000 to $120,000.

JOB SUMMARY: 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.

ESSENTIAL FUNCTIONS:

• 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.

EDUCATION & EXPERIENCE:

Process Validation Engineer I

• 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.

Process Validation Engineer II

• A minimum of 3-6 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.

Process Validation Engineer III

• A minimum of 6-10 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.

Senior Process Validation Engineer

• A minimum of 10-15 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.

KNOWLEDGE, SKILLS & ABILITIES:

Process Validation Engineer I

• 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.

Process Validation Engineer II

• All knowledge skills and abilities listed above.
• Proficient in MS Office, MS Project, Minitab Statistical Software
• Experienced at creating Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality, and budget.
• Knowledge of statistical tools such as Sampling Plans, Experimental Design and Optimization.
• Work independently – self-motivated.
• Knowledge or experience with quality audits is preferred

Process Validation Engineer III

• All knowledge skills and abilities listed above.
• Highly proficient in Minitab Statistical Software
• Proficient in the use of statistical tools such as Sampling Plans, Experimental Design and Optimization.

Senior Process Validation Engineer

• All knowledge skills and abilities listed above.
• Ability to analytically review protocols and reports.
• Knowledge and ability to participate in a quality system audit
• Mentor/Train less experienced personnel on validation methodology

PHYSICAL DEMANDS AND WORK ENVIRONMENT: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Sitting, standing and/or walking for up to eight hours per day.
• Frequently required to lift and/or carry up to 30 lbs.
• Occasionally required to push and/or pull up to 50 lbs.
• Occasionally required to stoop, kneel, crouch, crawl, and climb.
• Regularly required to talk and/or hear, see and perform repetitive motion.
• Occasionally required to see color and use depth perception.

GENEROUS LSI BENEFITS INCLUDE:

• 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

LSI SOLUTIONS® is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic.

Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran