Mississauga, Ontario, Canada · On-site
$62k–$83k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment…
Skills: Automation, Digital Transformation, Project Management, Computer System Validation, GMP
Whitby, Ontario, Canada · On-site
$56k–$85k/yr
Work Schedule Rotational M-F days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail…
Skills: Industrial millwright, Preventative maintenance, GMP, Machinery repair, Electronics
Bogota, Capital District, RAP (Especial) Central, Colombia · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Sr Clinical Trial Manager - Make an Impact at the Forefront of Innovation The Clinical Trial Manager is accountable for achiev…
Skills: Clinical Trial Management, ICH GCP, Clinical Monitoring, Trial Master File Management, Budgeting and Forecasting
São Paulo, São Paulo, Brazil · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Portfolio Governance, Project Analysis, Planview, Executive Reporting, PMO Standardization
Shanghai, Shanghai, China · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Key Responsibilities Enterprise Strategy & Business Partnership Serve as a strategic finance advisor to China business and functional leade…
Skills: Financial Planning, Commercial Finance, Strategic Planning, Pricing Strategy, Business Partnership
Melbourne, Victoria, Australia · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, …
Skills: Engineering, Chemical engineering, Mechatronics, Electronic engineering, Communication
Fremont, California, United States · On-site
$175k–$233k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Human resources strategy, Organizational development, Change management, Talent management, Performance management
Vilnius, Vilnius County, Lithuania · On-site
$1k–$2k/mo
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facia…
Skills: Product Packaging, Visual Inspection, GMP Compliance, SOP Adherence, Quality Control
Zhengzhou, Henan, China · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top …
Skills: Clinical monitoring, ICH-GCP, Regulatory compliance, Risk-based monitoring, Root cause analysis
Carlsbad, California, United States · Hybrid
$94k–$141k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Biologicals and Chemicals Division, or BCD, is a ~$1.7B business within the BioProduction Group. BCD supports our BioPharma partners in…
Skills: Financial analysis, Financial leadership, Operational performance, Revenue forecasting, Margin analysis
Boston, Massachusetts, United States · On-site
$24/hr–$33/hr
Work Schedule Second Shift (Afternoons) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings…
Skills: Materials Management, Inventory Control, cGMP Compliance, ERP Systems, Logistics Coordination
Bengaluru, Karnataka, India · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Siemens Teamcenter, PLM Application Support, Business Analysis, Requirements Gathering, Process Improvement
Suzhou, Jiangsu, China · On-site
Work Schedule First Shift (Days) Environmental Conditions Laboratory Setting Job Description Join Us as a Medical Technologist (Med Tech) – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, you’l…
Skills: Laboratory analysis, Hematological analysis, Coagulation analysis, Renal analysis, Lipid analysis
Bourgoin-Jallieu, Auvergne-Rhône-Alpes, France · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facia…
Skills: Industrial maintenance, Team management, Preventive maintenance, Corrective maintenance, GMAO
Morrisville, North Carolina, United States · Remote OK
$187k–$249k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Strategic account management, Commercial leadership, Clinical trial processes, Regulatory requirements, Relationship management
Beijing, Beijing, China · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation We have successfully supported th…
Skills: Clinical monitoring, ICH-GCP, Regulatory compliance, Risk-based monitoring, Root cause analysis
Greenville, North Carolina, United States · On-site
Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail po…
Skills: Environmental monitoring, GMP compliance, Cleanroom operations, Aseptic manufacturing, Instrumentation
Hsinchu, Taiwan · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Semiconductor Technology, Strategic Marketing, Technology Roadmapping, Advanced Logic, Advanced Packaging
Greenville, North Carolina, United States · On-site
Work Schedule First Shift (Days) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Batch record review, GMP compliance, Quality assurance, Quality control, Documentation management
Whitby, Ontario, Canada · On-site
$76k–$102k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail …
Skills: Industrial Hygiene, EHS Management, Risk Assessment, Occupational Exposure Limits, Incident Investigation
Mississauga, Ontario, Canada • On-site
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The Automation and Digital Projects Specialist leads the planning, development, and execution of digital transformation initiatives to improve operational efficiency and compliance. They facilitate business requirements, coordinate cross-functional teams, and support system validation and change management activities.
Candidates must possess a post-secondary diploma in Engineering, Science, or IT, with a minimum of 3 years of relevant experience in automation or digital project management. Proficiency in GMP, GAMP 5, and computer system validation principles within a regulated environment is required.
Reporting into the Digital Transformation department within Manufacturing Science and Technology (MSAT), the Automation and Digital Projects Specialist supports the planning, designing, development, and execution of automation and digital transformation initiatives that improve operational efficiency, compliance, and business performance. The role independently leads projects and supports larger cross-functional initiatives by facilitating business requirements, coordinating stakeholders, managing project deliverables, and assisting with design, implementation, software validation, and change management activities. Working closely with Operations, Quality, IT, Engineering, and business stakeholders, this individual ensures digital solutions are implemented and maintained in accordance with company standards and applicable regulatory requirements.
Post secondary diploma in Engineering, Science, Computer Science, Information Technology, or a related discipline.
Bachelor’s degree in computer science or engineering is an asset.
Minimum 3 years of relevant experience leading or supporting projects involving digital technologies, automation, business process improvement, project management, or computer system validation within a regulated environment.
Minimum 2 years Information Technology expertise and experience with IT Infrastructure and IT Application implementations.
Exposure to pharmaceutical environment an asset. Project Management experience is asset.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Working knowledge of Good Manufacturing Practices (GMP), GAMP 5, 21 CFR Part 11, and computer system validation principles. Understanding of automation concepts, system integrations, APIs, data flows, and software implementation lifecycles with digital solution product development. Experience designing and implementing business process automation solutions using low-code/no-code platforms, scripting, reporting tools, or similar digital technologies. Familiarity with User Requirement Specification (URS) generation and User Acceptance Testing (UAT), software implementation, and change management. Excellent written and oral skills with ability to translate business requirements into practical digital or automated solutions through facilitations and workshops. Ability to communicate technical concepts to non-technical audiences and vice-versa. Knowledge of waterfall and agile project management methodologies and software implementation lifecycles. Strong analytical, organizational, problem-solving, and stakeholder management skills. Strong judgment, decision making and troubleshooting skills. Ability to multi-task, meeting tight deadlines in a fast-paced environment. Proficiency with Microsoft Office programs. Proficiency with the English Language.
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. Carry out 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 a proactive manner. Consistently strives to improve skills and knowledge in related field.
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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
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.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
