- Develops, plans, and executes automation and controls capital projects through the entire project lifecycle (scoping, design, procurement, construction, installation, and commissioning)
- Leads automation and controls specific projects from start to finish.
- Supports the automation and controls workstream in capital projects led by the Capital Engineering team.
- Supports projects through Commissioning, Qualification, and Verification and ensure all automation and controls project deliverables are achieved.
- Contributes to the definition, implementation, and maintenance of standard operating procedures as it relates to automation & control systems across the facility.
- Generates URS and IOQ documents as required.
- Reviews URS, SDS, HDS, electrical drawings and specifications, piping and instrumentation diagrams, and I/O lists.
- Reviews, analyzes, and revises existing programs as required for updates/upgrades to PLC logic.
- Functions as the site-wide subject matter expert on PLC, SCADA, & MES systems.
- Offers escalation support for the Maintenance Equipment Services Team to provide technical support post-equipment installation or production related issues which includes regular, off-shift and weekend coverage as required.
- Prepares training manuals and deliver technical training to Operations and Maintenance team members for new systems.
- Gathers and analyzes data and technical information to support Continuous Improvement (PPI) and Capital Projects.
- Supports Factory Acceptance Testing (FAT) at OEM facilities and Site Acceptance Testing (SAT) at Thermo Fisher Scientific facilities.
- Ensures all equipment and work performed by or on behalf of the company complies with all governing laws, practices, codes, and regulations including CFR 21 Part 11.
- Leads the development of the Pharma roadmap for the site and the standardization of process and packaging equipment solutions for common applications.
- Ensures that third-party vendors and contractors under your supervision receive detailed safety instructions before they start work.
- Ensures that third party vendors or contractors under your supervision work in compliance with health and safety-related legislation and company's health and safety program.
- Mentors and coaches other team members within the Automation & Controls Engineering Department.
- Travels within the local Thermo Fisher Scientific sites as well as internationally to supplier locations and industry trade shows may be required.
- Maintains a safe working environment and report potential hazards.
- Performs alternating or rotating shift work (as required)
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Sr Automation - Whitby, Canada - Thermo Fisher Scientific
Description
Responsible for scoping, defining, leading and implementing automation & controls systems for pharmaceutical manufacturing equipment through capital projects. This includes defining system standards, reviewing vendor proposals, and managing third party integration partners. In addition to projects, this role will have a support function to stakeholders within the site for automation and controls troubleshooting purposes. The successful candidate will be the site subject matter expert on the Manufacturing Execution System and PLC and SCADA systems.
What will you do:
How will you get here:
Education:
Minimum Bachelor's degree in Engineering. Specialization in Electrical, Mechatronics, or Industrial Automation / Instrumentation, preferred.Professional Engineer Designation is an asset.
Experience:
Minimum 5 years automation and controls experience in a GMP and/or regulated environment.
Experience with manufacturing execution systems is required, preferably Rockwell Automation PharmaSuite.
Project management experience is required.
Robust knowledge of 21 CFR Part 11 is required.
Equivalency :
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Ability to read, analyze and interpret electrical schematics, control panel drawings, technical procedures, process & instrumentation drawings, engineering drawings, and government regulations. Experience with PLC/VFD/HMI Programming, industrial networks configuration/troubleshooting, SQL Server, PI Historian. PlantPAx DCS, Kepware OPC, and Ignition SCADA software certifications are an asset. Proficiency with 21 CFR Part 11 requirements and GMP systems. Understanding of Validation & IQ/OQ/PQ program. Strong judgment, decision making abilities, troubleshooting and thinking-out-of-the-box skills. Excellent organizational, verbal, and written communication skills. Solid computer experience with MS applications(Project, Word, Excel).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:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab 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; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; 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. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
