| Urgent Need : Lead Validation/CQV Engineer at Kalamazoo, MI | Onsite role | at Kalamazoo, Michigan, USA |
| Email: [email protected] |
| Hi, Please find job description below; VISAS- No-h1b RATE- $50. Hr on C2C max Need LinkedIn TITLE- Lead Validation/CQV Engineer Duration- 6+ months contract Location- Onsite in Kalamazoo, MI Interview- telephonic and Video Automation CQV Lead ROLE SUMMARY The MAP Digital Plant team is tasked with designing, implementing, commissioning, qualifying and supporting the digital systems that will support and enable the manufacturing of aseptic medicines in Pfizer Kalamazoos world class Modular Aseptic Processing facility. The Digital Plant Compliance Lead will provide strategic and tactical direction on the compliance aspects of all of MAPs digital systems. Compliance duties include negotiating strategies with quality, leading data integrity assessments, updating and creating strategic standard operating procedures, implementing new methodologies, and mentoring automation engineers in compliance methodology as well as audit representation for automation systems. ROLE RESPONSIBILITIES Improving the compliance footprint for the automation organization by implementing continuous improvement practices for the automation team to follow related to regulatory, corporate, and site policies and practices. Preparation and representation for automation in regulatory and customer audits. Communicating and collaborating with operations and automation colleagues to manage and/or perform user account reviews Updating Data Integrity Assessments and routing them through change control Performing/managing records retention tasks Managing automation department compliance methodologies, strategies, systems and standards including Data Integrity, SOP periodic review, CAS reviews, and other documentation. Assisting Cybersecurity lead with strategy, methodologies and documentation of process and procedures from a compliance perspective. Assisting Infrastructure lead with strategy, methodologies and documentation of process and procedures from a compliance perspective. provide 24x7x365 support of our automation systems from a compliance perspective including assisting automation engineers when emergencies arise to have issue properly addressed and documented. Participate in the Engineering Compliance Services team representing automation. Review system support documentation to ensure compliance clearly communicate progress and issues to peers and management Assist in training and mentoring site Automation Technicians, Analysts, and Engineers. Monitor and trend issues to identify and develop preventative solutions BASIC QUALIFICATIONS Bachelor of Science degree in a technical field such as Electrical, Mechanical, Chemical, or Computer Engineering, or Computer Science. Nine or more years of Automation Engineering experience. Proficiency in Excel, Word, Powerpoint, Sharepoint, Teams Good Organizational skills and can meet project task deadlines Proven ability to work in team environment and contribute as a team member Ability to learn new technologies and adapt to change PREFERRED QUALIFICATIONS The ideal candidate should have background in cGMP regulations and the practical application of those methodologies to control systems. System technical knowledge, such as MS Windows Server, Active Directory, SQL Server, VMware, vSphere, vCenter, Cisco, Networking and OSI PI. Experience building systems and installing patches Regards, Vijay Kumar | Lead Recruiter Trail Blazer Consulting LLC | Astoria, NY 11105 Office: 914-650-4600 Ext: 148 Keywords: microsoft Michigan New York |
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| Wed Feb 07 20:31:00 UTC 2024 |