Join us as We Transform How Pharmaceuticals are Made.
|Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
The Manufacturing Systems Engineer is responsible for supporting the manufacturing Operational Technology infrastructure and the sites automation applications used at the St. Louis GMP facility. The role is responsible for supporting the reliable operation of manufacturing networks, servers, databases and automation application within GMP environment on a 24/7 basis.
The right individual will support projects associated with new and existing process installations, including but not limited to design, start-up, commissioning and mechanical/electrical installation.
The primary responsibility of the OT-MSE can be broken down into the following specific activities;
- Maintain and monitor manufacturing infrastructure and system to corporate and site policies.
- Maintain compliance for software and hardware licensing.
- Provide technical leadership and support services for network hardware, Firewalls, Domains & Trusts, VMware, Windows Server, storage, security and Backup solutions for manufacturing systems.
- Maintain Active Directory and related network systems.
- Develop and implement solutions to improve manufacturing operation, such as establishing trust between manufacturing networks. (security, NTP sync, etc.)
- Identify and integrate varied data sources to improve manufacturing visibility.
- Maintain network, switches, servers and server Netbackup/restore processes
- Install and maintain network, server, storage, security
- Develop system monitoring tools for proactive monitoring and alerting of core responsibilities
- Identify, isolate and correct network equipment problems
- Research and recommend useful technologies
- Respond to emergency situations in manufacturing, laboratory or office settings.
- Uses process / system knowledge to help lead technical decisions associated with automation, mechanical and electrical fixes throughout GMP/PD processes.
- Supports major capital project review.
- Understands process equipment control systems, programming and how to implement control systems in a GMP environment.
- Leads site automation/controls project planning, execution and maintenance.
- Is integrated in the manufacturing support engineering team as automation/OT lead.
- Coordinate and participate in LAN/WAN/Windows Server planning activities
- Coordinate projects with vendors and customers as required
- Perform configuration and define parameters for installation and testing of LAN/WAN, routers, switches, and other related server and networking equipment
- Perform configuration, maintenance and testing support for VMware and Windows Servers
- Use computers, monitoring and testing equipment to determine responsible system performance
- Understand and implement appropriate communication protocols to collect/archive manufacturing data. ( ie. TCP/IP, OPC, SQL Scripting, etc.)
- Take corrective action to improve legacy system performance
- Prepare equipment specifications
- Prepare standards and guidelines for network implementation
- Make decisions, based on the professional judgment, experience, and the ethical guidelines of good business practices
- Assist in special projects as necessary
- Implement solution to comply with cGMP and DI requirements.
Education & Experience:
- Bachelor’s degree in Engineering, Computer Sciences or related field preferred. Technical degree with proven experience may be considered.
- 5+ years of experience as a support specialist of infrastructure including desktop, server, networking, and manufacturing equipment in a manufacturing or enterprise environment.
- VM-Ware ESXi or more recent experience preferred
- Windows Server 2000 - 2008 experience required, 2012 and above preferred.
- Cisco switch and firewall experience required.
- Demonstrated experience in creating IT plans to meet business growth models.
- Experience in leading the deployment and maintenance of an IT infrastructure system to support manufacturing automation systems.
- Experience with automation technology like, Rockwell FTView, GE Prificy, Historians, etc.
- Detailed knowledge of GMP and other pharmaceutical regulations from FDA, EU, ICH and PICs guidelines preferred.
- Proven ability to form teams and produce desired results through direct reporting.
- Expert knowledge of LAN infrastructure as it relates to manufacturing processes. troubleshooting, bio-process requirements, best-in-class maintenance practices.
- Expert knowledge of network and hardware troubleshooting best-in-class maintenance practices.
- Ability to function in a small team environment, providing a responsive service to internal customers and balance multiple priorities simultaneously.
- The individual selected for this role must be a logical problem solver, works responsively servicing the users on site
- The ideal candidate will have both strong interpersonal skills and technical expertise with the ability to make logical decisions after assessing technical situations
- Good verbal and written communication skills
- The individual must be very well organized
- A balance of flexible customer focused responsiveness and proactivity is required
- Advanced computer skills with SQL, MS-Excel, MS-Word and MS-Outlook required
- Understanding of CFP21, especially part 11.
- A flexible work schedule is required.
- This role will be based in St. Louis.
- This job description is not all inclusive, other duties may be performed as assigned.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Help Us Make a Healthier World.
|Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.