Ortec has been providing custom chemical solutions and personalized service since 1980. With three plants and over 300 employees, we can meet the production needs of our customers while maintaining a high level of personalized service. We are large enough to get the job done, yet small enough to care. Even as the company grows and develops new services, we never forget the values that made us who we are as a company.

We are a team. A family. A group of smart, talented, big-hearted individuals working together for the success of our customers and the growth of our communities.

AND WE HONOR OUR COMMITMENTS

What we do at Ortec is complicated at times. Why we do what we do is not complicated: We want to make a difference for our customers and our communities around us. How we do what we do is also not complicated: everything starts with Integrity.

WHY ORTEC? The foundation of Ortec is our talented, dedicated employees. Our commitment to delivering chemical manufacturing services with measurable quality has made us a trusted partner to some of the most familiar names in business. Our success is drawn from the experience, energy and teamwork of our employees, who consistently deliver results by anticipating change and executing solutions with confidence and passion. At Ortec, you'll be working with the latest technologies and tools, not to mention some of the industry's best and brightest minds. From the top down, this type of commitment and energy is radiated throughout the company. The result is a growing, dynamic, and rewarding place to work a company where we work as many, and we win as one. You are a name, not a number!

We offer an excellent benefit package, including:

• Medical, Dental, and Vision Insurance
• Company Paid Short-Term Disability, Long-Term Disability and AD&D
• Annual Anniversary Cash Award
• On-Site Nurse
• Company Paid Employee Assistance Plan
• 401k with match
• And much more...

Position Summary:

The primary objective of this position is to manage and lead computer system implementation and validation projects within the Life Sciences Division to ensure they are maintained in a controlled and compliant state.

This role provides validation and compliance consulting and project support on various technology development and implementation projects, including documented plans, test scripts development, testing, and support. The Computer System Validation Specialist will also be responsible for oversight of all GMP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer System Validation procedures, and Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.

Essential Duties and Responsibilities:

• Leads computer system implementation and validation projects with the ability to manage multiple and complex projects including:
• Applying site's system development lifecycle and project management methodologies
• Creating and tracking project work plans using project management tools
• Identifying resource and budget needs
• Managing the project tasks and resources to meet the project schedule and deadlines
• Communicating project status to management
• Identifying, communicating, and resolving issues in a timely manner
• Develops and reviews computer validation strategies including the development and review of computer validation documents such as user requirements specifications, validation plans, function and design specifications, testing protocols, risk assessments, and validation summary reports.
• Understands the business issues, business processes and data challenges of a manufacturing site in the pharmaceutical industry. Builds relationships with system owners and communicates business requirements to QA management. Makes recommendations and implements improvements with customer involvement.
• Serve as the liaison between IT and QA for evaluating proposed changes to shared systems
• Provides timely direct support on the technical-based needs of the end-user community with emphasis on the IT systems for which he/she is directly responsible, and supports other systems as required. Including implementing appropriate controls and developing and revising standard operating procedures.
• Maintain schedule and performs computer system periodic reviews as required
• Operate within the company's standard operating procedures and review and approve appropriate procedures for area of responsibility to ensure compliance with ISO 9001, 13485, cGMP, customer and Ortec requirements
• Maintain expertise in current and emerging cGMP requirements and quality trends
• Serve as SME during Audits and Inspections providing data reports and updates related to all Computer System Validation
• Other duties as assigned

Education & Experience:

• Bachelor's Degree in Science Related field
• Experience with the management, development, and/or validation of computerized systems, 3-5 years minimum required
• Knowledge of test and/or equipment qualification preferred
• Experience with cGMP Quality Assurance or quality systems 3-5 years minimum
• Experience in ISO 9001 and/or 13485, 21 CFR 210 & 211, 21 CFR 820, and EU GMP's required
• Demonstrated strong project management skills
• Certifications preferred such as CQE, Green Belt, etc.

Skills & Abilities:

• Strong technical, analytical, interpersonal, communication, and writing skills
• Ability to work in a team setting
• Ability to manage multiple projects
• Collaboratively work with IT and the Life Science organization to assure alignment in validation plans and processes with focus in compliance achievement.
• Good interpersonal skills with ability to analyze situations, present alternatives, and lead team to establish/ define solutions and related action plans.
• Must be able to effectively work in a fast-paced environment, be flexible, and possess the ability to adapt to shifting priorities, to work independently as well as part of a team
• Be proficient in computer skills such as Word, Excel, PowerPoint, and Visio
• Knowledge of lean concepts and efficient business process management
• Knowledge of GAMP 5 concepts and Regulatory compliance