Job Description:
Automation Compliance Manager will oversee VEQTOR’s CSV and will provide mentorship and risk-based CSV guidance, and development oversight. The Automation Compliance Manager will interact with clients to identify their needs, partnering towards solutions that meet schedule, cost, and compliance expectations and requirements. Lead project teams or work independently as a CSV Subject-Matter-Expert with strong process knowledge (design through qualification).
Principal Job Duties & Responsibilities:
Planning & Training
- Accountable and responsible for providing a planned, documented, and managed VEQTOR’s approach to the risk-based CSV program based on latest industry trends, i.e., ISPE GAMP 5, 2nd Edition and Computer Software Assurance
- Support companywide efforts to mentor VEQTOR’s CSV/CQV organizations and in effective, efficient, sustainable, and compliant use of risk-based strategies described in ISPE GAMP5, 2nd Edition and Computer Software, and ISPE Baseline C&Q guide, 2nd Edition
- Incorporate new team members through coaching and/or other orientation practices used at VEQTOR. Work with Directors to suggest efficiencies and further effectiveness of current practices
- Enhance employees’ skills, performance, and development by applying VEQTOR training programs so that adherence to risk-based methodologies is ensured and work of the highest quality prevails
- Develop ways to continually improve VEQTOR’s personnel’s technical and organizational knowledge and project management skills
- Manage CSV personnel and provide an environment for the development and professional advancement of staff members, including on-the-job and formal training and development opportunities, and timely performance feedback. Balance project needs with work-life needs of employees
- Analyze situations, identify, and forecast pertinent problems, evaluate realistic options, and recommend/implement appropriate course of action. Utilize VEQTOR’s corrective action (CAR) process for continuous improvement
Client Specific CSV Project(s)
- Support VEQTOR’s CSV operations in Midwest and RTP area by ensuring CSV projects are completed successfully with met objectives. And help to ensure compliance with the Client’s Corporate quality guidelines and alignment with ISPE GAMP5, 2nd Edition and Computer Software Assurance guidelines
- Conduct monthly client meetings and maintain a close client relationship with client’s management. Focus substantial efforts on nurturing existing relationships
- Develop and manage a team of CSV specialists and engineers in the Midwest and RTP to meet CSV project demands
- Ability to generate project budget proposals based on a client’s Request for Proposals (RFP)
- Manage the work to the terms of the contract by eliminating leakage and optimizing returns
- Fulfill contract requirement by ensuring that the duties and responsibilities of the project contract are clearly defined, documented, and followed by the VEQTOR team
- Prepare project specific staffing plans including man-hour estimates
- Organize and prioritize a variety of complex projects and multiple tasks in an effective and timely manner, set priorities, and meet the critical time deadlines
- Independently and with minimal oversight initiates, plans, provides direction, execution, and follow up of CSV projects
- Support Director of Automation with automation compliance projects in life cycle management, data integrity and data security, especially in early strategy and planning phases
- Be able to develop and maintain the system centric integrated CSV schedule with CQV in many instances. This role will require abilities and previous experience in project management that includes control all costs associated with CSV labor and systems
- Lead or participate in client’s CSV/OT Core risk management reviews and follow up with mitigation planning and execution
- Manage risk as assigned by the joint Risk Assessment for systems, project management, and or site management by reviewing risk on a regular basis and identifies significant business risk for the project(s)
- Prior hands-on experience in risk-based CSV and OT/IT system life cycle management
Kneat Paperless Services & Support:
- Support VEQTOR organization and promote VEQTOR approaches and best practices to CSV by utilization of Kneat paperless in client interactions, trade shows, industry’s discussions, seminars, etc.,
- Serve as a SME for CSV Kneat Gx workspace. Note this will require to go through levels of training, testing and certification process. The highest level of training is Superuser / master trainer level
- Become Kneat Superuser and conduct client demos, internal and external training
- Support VEQTOR’s CSV content development, deployment, and client implementation of VEQTOR’s internally developed package
- Work with Director of integrated C&Q and Paperless Strategy to identify additional areas of improvement and broaden the use of the Kneat Gx platform in CSV and OT/IT life cycle management
Qualifications / Requirements:
- Bachelor’s degree in Engineering, Computer Science, or equivalent experience
- Proven track record of resource and project management and training in CSV, both for manufacturing control systems and enterprise IT systems (min 5 years)
- Direct validation experience and knowledge of DCS DeltaV and AB, Siemens, or Wonderware PLCs/SCADA (min 5 years)
- Experience in writing specific procedures for OT and or IT asset life cycle, such as life cycle documents, account management, disaster recovery, patch management, etc.
- Detail oriented, self-motivated and a team player
- Ability to work in a fast-paced, high-energy environment both in managing and contributing directly to the project’s deliverables
- Ability to perform critical analysis of situations and provide recommendations
- Problem solving, creative thinking, and interaction with upper management and design teams
- Ability to work independently with structured guidance
- Possess excellent interpersonal, organizational, writing and communication skills
- Ability to uphold VEQTOR values and demonstrating honesty, integrity, pride, accountability, teamwork, and commitment