Work Schedule Standard (Mon-Fri) Environmental Conditions Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Summary: Responsible for driving automation & controls related capital projects for pharmaceutical manufacturing equipment. This includes supporting the definition of system standards, reviewing vendor proposals, and managing third party integration partners. The successful candidate will also serve as on-site support for resolving maintenance issues related to automation and controls, including customer concerns and partner concerns. Essential Functions: Develops, plans and completes automation and controls related capital projects from start to finish (prioritising, design, procurement, construction, installation, and commissioning) 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 standards and SOPs for the site as it related to automation and controls. Reviews URS, SDS, HDS, electrical drawings and specifications, piping and instrumentation diagrams, and I/O lists. Reviews, analyzes, and revises existing programs as the need arises for updates/upgrades to PLC logic. Supports Quality investigations regarding electronic data and equipment reliability. Assists the Maintenance Equipment Services Team in resolving customer concerns and partner issues following equipment installation, with availability during regular hours, off-shifts, and weekends as necessary. Prepares training manuals and deliver technical training to Operations and Maintenance team members for new systems. Creates and manages Change Control process for entirety of project execution. 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 ThermoFisher Scientific facilities. Ensures all equipment and work performed by or on behalf of the company aligns with all governing laws, practices, codes, and regulations. Contributes to the development of the Pharma 4.0 roadmap for the site and the standardization of process and packaging equipment solutions for common applications Ensure that third-party vendors and contractors under your supervision receive detailed safety instructions before they start work. Ensure 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 junior team members within the Automation and Controls Engineering Department. Travel within the local ThermoFisher Scientific sites as well as internationally to supplier locations and industry trade shows may be required. Performs alternating or rotating shift work (as required) REQUIRED QUALIFICATIONS Education: Minimum Bachelor’s degree in Engineering. Specialization in Electrical, Mechatronics, or Industrial Automation / Instrumentation, preferred. Professional Engineer Designation is an asset. Experience: Minimum 3 years experience in an automation and controls related position in a GMP and/or regulated environment. Experience with Allen Bradley Systems such as ControlLogix and PlantPAx Experience leading capital automation and controls projects Page 1 of 3 Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, Abilities: Ability to read, analyze and interpret electrical schematics, control panel drawings, technical procedures, process & instrumentation drawings, engineering drawings, and government regulations. Skilled in PLC /HMI Programming, proficient in fixing and solving challenges related to industrial networks. PlantPAx DCS, Kepware OPC, and Ignition SCADA software certifications are an asset. Proficiency in GMP systems. Understanding of Validation & IQ/OQ/PQ program along with 21 CFR Part 11. Strong judgment, decision making abilities, trouble shooting and thinking-out-of-the-box skills. Excellent organizational, verbal and written communication skills. Solid computer experience with MS applications (Project, Word, Excel). Knowledge of AutoCAD. Proficiency with the English language. Standards and Expectations: Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order 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. Models 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. Ensure timely communication of any potential risks that could impact the completion of the work. Consistently strives to improve skills and knowledge in related field. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about manufacturing/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 up to 40 pounds; arm, hand and finger dexterity; visual acuity to 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. Usually in a comfortable environment but with regular exposure to factors causing moderate physical discomfort from such things as dust, loud noise, bright lights, fumes or odour. Use of Personal Protective equipment is required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator. Disclaimer: 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 a comprehensive statement of work, 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 align 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. 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.
