PharmEng Technology ยท 16 hours ago
Sr Automation Engineer
PharmEng Technology is seeking a Sr. Process Automation Engineer for a contract-to-hire position. This role offers an exciting opportunity to support manufacturing operations through technical expertise in automation systems and instrumentation, ensuring optimal production efficiency and compliance.
ConsultingInformation TechnologyPharmaceutical
Responsibilities
Provide 24x7 automation support to manufacturing by troubleshooting equipment, systems, and processes
Support ongoing production operations and the introduction of new equipment and processes
Participate in off-shift and on-call rotation as needed
Offer operational support on the manufacturing floor
Assist in evaluating historical process and equipment data
Act as a subject matter expert (SME) for cross-functional groups such as QA, QC, PD, and engineering teams
Mentor and train junior team members, including technicians, analysts, and engineers
Develop and support training plans for site personnel
Communicate progress, opportunities, and roadblocks to leadership and stakeholders effectively
Serve as the owner and administrator for manufacturing equipment and systems
Conduct periodic reviews and manage training and access for automation systems
Oversee regulatory aspects of data collection, monitoring, and SCADA systems, including CMS, BMS, and OSI Pi
Manage backups and restoration of automation configurations
Support and maintain OT networks and control systems
Enhance process control through advanced automation concepts
Develop and implement automation standards, SOPs, and design documents
Author and review specifications for projects and process changes
Ensure adherence to site automation standards in project implementation
Develop and support change controls, deviations, investigations, and CAPAs
Review and approve validation protocols and related documentation
Support audits and regulatory inspections
Ensure compliance with IT/OT security policies, data integrity, and regulatory requirements
Incorporate innovative technologies into equipment and process designs
Develop automation requirements and specifications for new systems and process improvements
Qualification
Required
Extensive experience in process automation and manufacturing environments
Proven ability to manage projects involving complex equipment and significant process improvements
Strong knowledge of FDA 21 CFR Part 11, Annex 11, and data integrity requirements
Excellent troubleshooting, communication, and leadership skills
Preferred
Hands-on experience with OSIsoft PI (DHS)
Hands-on experience with Vaisala viewLinc (CMS)
Hands-on experience with Rockwell Software Suite
Hands-on experience with Automated Logic WebCTRL
Hands-on experience with Wonderware System Platform
Hands-on experience with Windows OS
Hands-on experience with DCS systems
Hands-on experience with Industrial communication networks
Company
PharmEng Technology
PharmEng Technology is a pharmaceutical company that provides consultancy services.
H1B Sponsorship
PharmEng Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase