The Validation Engineer will be responsible for the lifecycle management of various commissioning, qualification, and validation facets within our sites. This support service will be performed working with internal and external customers, project management, Design and Manufacturing Engineering, Operations, and Quality teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Validation strategy, Design Qualification (DQ), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV), Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, and calibration)
Understanding and experience in maintaining a system’s validated state, which includes Change Control, GMP Investigations, CAPA, NCR, Post Market, Preventive Maintenance, Calibration, Periodic Review, Phase III PPQ, among other subsystems and programs.
Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards
Provide assistance to Manufacturing Engineering and Operations teams with execution of validation-related deliverables
Experience with standard industry process and packaging equipment, which may include: Control Box equipment (e.g. PLCs, HMIs, etc) and CNC
Experience utilizing problem solving techniques and investigational tools
Statistical data analysis and sampling plans
Trend and pattern analysis
Technical writing, document control, and organizational skills a must.
Comfortable with manufacturing environment
Works well with others, within a team and takes accountability
Strong interpersonal and communication skills (verbal and presentation)
Organized, with strong computer literacy such as MS Project, Excel, etc.
Excellent interpersonal skills, result driven, self-motivated, and autonomous
Bachelor’s degree in Engineering or Technical discipline
Five (5) years of core validation experience within technical/regulated industries (e.g. Pharmaceutical or Medical Device)
Knowledge of industry V&V expectations and requirements (e.g. FDA guidelines, USP, GAMP 5, ISO13485, etc.)
TIDI Products is a global manufacturer of single-use medical, dental, film and food service products. We believe our employees and our customer service distinguish us from our competitors. TIDI Products has a strong commitment to its employees, and we are proud of the men and women who make TIDI the company that it is. Our seasoned workforce of engaged, diverse employees is at TIDI’s foundation. T...IDI is committed to producing the best results possible and to provide an atmosphere where our employees can grow with the company and achieve personal success.
TIDI Products offers a competitive salary and benefits package, including a 401(k) with a matching provision, profit sharing, comprehensive group medical, dental, short-term disability, long-term disability, and life insurance. TIDI also offers a vacation package and celebrates ten paid holidays.
As an employee with TIDI Products, you are able to participate in extra incentives such as, thank-you lunches, gift cards for a job well done, service awards, birthday recognition, holiday gifts, appreciation dinner and the annual Children’s Holiday celebration.
It is the policy of TIDI Products, LLC to provide equal employment opportunity to all individuals regardless of their race, creed, color, religion, sex, age, national origin, disabilities, veteran status, marital status, sexual orientation, military status, genetic information, or any other characteristic protected by state or federal law. We are strongly committed to this policy and believe in the concept and spirit of the law.