Job Description

 We are currently looking for a DATA INTEGRITY – COMPUTER SYSTEM AUTOMATION EQUIPMENT VALIDATION CONSULTANT for our direct client in St. Louis MO on a Contract basis.

JOB DESCRIPTION

DATA INTEGRITY – COMPUTER SYSTEM / AUTOMATION EQUIPMENT VALIDATION role will take direction from the Data Integrity Manager to support and enhance the quality and compliance operations with respect to Data Integrity. This role will work with the Quality and Compliance department. This includes assisting with ensuring systems meet data integrity requirements (ALCOA AND 21 CFR PART 11). This role will be responsible for the authoring / review of solution development lifecycle documents (SDLC) i.e. standard operating procedures, user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans. Use different software, laboratory and automation equipment at both the Westport and Brentwood locations. This role will work on operations support (User Account Reviews, Periodic System Reviews, Change Controls, Assessments, etc.) and project support for automation and laboratory systems.

RESPONSIBILITIES:

• Provide technical and compliance expertise to assist with writing of SDLC documentation (software, laboratory, production) in accordance with local procedures, templates, regulatory requirements (e.g., 21 CFR Part 11, 211, 820), and Quality System Standards.
• Expert experience in CFR 21 Part 11 and data integrity concepts – specific to logical, procedural and technical/engineering control.
• Assist, as needed, with the development of sound software and lifecycle validation strategies that are balanced with design, quality, and risk that are defensible and supportable by the business and Quality Compliance organization.
• Provide technical and compliance expertise to support the continuous improvement of Quality Compliance Departmental operating procedures and processes.
• Assist in performing change control impact assessments and work with technical subject matter experts (SMEs).

QUALIFICATIONS:

• Bachelor’s degree in Computer Science, Information Technology or other science-related discipline.
• 5+ years’ of experience in pharma/device or other regulated industry.
• 5+ years’ of experience in managing projects, facilitating meetings and resolving conflict.
• Must be able to work independently and complete assignments on time and clearly communicate progress, challenges to meet timeline and recovery plan.
• Must have a solid background and understanding of electronic systems software and hardware architecture, process control systems and HMIs.
• Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).
• Excellent organization skills with the ability / flexibility to react to changing deadlines and priorities.
• Must have demonstrated capability in completing projects according to prescribed timelines and other requirements in previous project management or business analyst roles.
• Solid work ethic with a positive attitude; excellent listener, with good verbal and communication skills.
• Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
• Familiarity with lab systems, plant automation systems, Change Control and CAPA processes.
• Be able to function in multidisciplinary teams, must possess excellent documentation, presentation, training and computer skills.
• Ability to work effectively with a diverse workforce.

Travel between St. Louis locations will be required

Company Description

We’re committed to empowering each individual who works with us to take charge of their career. You won’t be alone on your journey. Our dedicated team is here to serve you as a partner in the process. What we offer for you: Interview preparation Resume review and recommendations LinkedIn review Local job market information, trends, and insights Access to networking events Informational career centric seminars. Neteffects Consultant Care Program: Keeping in Touch: Whether it’s a quick call or email, coffee or lunch, our check-ins support as much or as little interaction as you’d prefer. We’re here if you need us. Events: Neteffects participates in a number of events each year and hosts some employee-only social gatherings. Remarketing: When your project is nearing completion, we’ll partner with you to get you ready to engage in your next consulting opportunity through Neteffects. From resume review, to interview preparation and offer negotiation; we’ll work hard to help you excel. Neteffects Benefits: Neteffects is about celebrating technology and the pro's that come with it. We offer a very competitive benefits package, which includes Medical, Dental, Vision, Life, 401k, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.