Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Summary: This role uses engineering principles and process knowledge to fulfill the gap for OT support at the site. Provide 24/7 support of manufacturing process equipment operation and maintenance as well as provides technical leadership to improve and enhance process automation functions. The role has a focus on infrastructure and supporting technology around the plant’s complex automation systems, Security, and Data Integrity. Responsibilities include support of VMware, Windows Server, Microsoft Active Directory, and LAN\WAN support-based activities, and troubleshooting of same systems. Also responsible for providing focus on the analysis, deployment, and implementation of technical solutions to support the business and Data Integrity (DI) Compliance. Providing the technical skills required for the installation, operation, and optimization of digital network communication equipment. Responsible for installing and maintaining network communication between equipment, and software necessary for terminals, workstations, personal computers, and mainframe computers to effectively communicate over a computer network. Proactive problem solver with strong collaboration skills cross-functional teams and business units. Assist in building and maintaining a secure, scalable, and compliant Thermo Fisher IT/OT manufacturing environment. Essential Functions: Provide hands-on technical support to manufacturing staff, addressing hardware, software, and networking issues in a timely manner. Collaborate with IT, global engineering, site engineering & facilities, Quality and Compliance teams to ensure GxP guidelines are followed, including data integrity, audit trails, and documentation practices. Implement and maintain IT solutions in compliance with CFR 21 Part 11 and IEC 62443 standards, ensuring security and data integrity within manufacturing and laboratory environments. Install, configure, and maintain OT equipment, including computers, servers, and specialized manufacturing equipment, while ensuring they meet compliance standards. Required on initial installation and continuous operations. Participate in the planning and execution of DI remediation & production projects related to new equipment deployments, system upgrades, network enhancements, and software implementations within manufacturing and laboratory settings. Troubleshoot and resolve technical issues related to software applications, operating systems, and network connectivity to minimize downtime and disruptions. Collaborate with vendors and third-party service providers for equipment maintenance, repairs, and upgrades. Offer training and support to end-users on IT/OT tools, applications, security practices, and compliance requirements to enhance overall system knowledge and awareness. Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work (as required) Education: Bachelor’s degree in information technology, Computer Science, Electrical Engineering Experience: Minimum 5 years of experience in Operations Technology support role within manufacturing, laboratory, or other regulated environments. Minimum 2 years experience with networking concepts, protocols, and configurations GMP experience and/or experience deploying, maintaining, and developing validated systems in regulated healthcare environments preferred. Knowledge, Skills, and Abilities: Solid understanding of GxP regulations (GMP, GLP, GCP), CFR 21 Part 11, and IEC 62443 standards, and experience implementing IT solutions in compliance with these guidelines. Familiarity of platforms such as RAFT (Rockwell Automation Factory Talk), Sotax & Q-Doc application, FTPS (Factory Talk PharmaSuite), SCADA, DLH, Korch Tablet Press, GEA PMA MP2 Systems and other production systems preferred. Familiarity with laboratory instruments and software commonly used in scientific research and data analysis. Ability to work in a team structure, make decisions, solve problems, communicate inside & outside the organization, and analyze, plan, organize and prioritize work, partnering with Engineering and Global IT to support IT/OT and Industrial cybersecurity. Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and end-users. Ability to adapt to evolving technologies and work in a dynamic, fast-paced environment. Experience in leading the deployment and/or maintenance of a manufacturing IT/OT infrastructure system Tool & Technology Skills. Windows and/or Linux systems administration and/or network device management. Ability to troubleshoot, diagnose, and resolve issues on the manufacturing equipment and 3rd party applications supported by vendor and engage functional teams as needed. Dynamic, hard-working, and ambitious, with excellent oral and written communication skills. Capable of working on multiple projects of a complex nature. Excellent problem-solving skills to assist in issue resolution. Excellent verbal and written communication skills. Ability to translate business requirements into technical designs to meet business needs. Self-starter with high level analytical skills combined with thorough documentation abilities. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language. Standards and Expectations: Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Perform all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in an initiative-taking manner. Consistently strives to improve skills and knowledge in related field. Physical Requirements: Light physical effort and fatigue. Walks, sits, or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator occasionally. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
