Lead Automation Systems Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Thermo Fisher Scientific Inc., a global leader in scientific services, as a Staff Engineer, Systems Design. This is an outstanding opportunity to contribute to world-class advancements in engineering, working with a dynamic team dedicated to innovation and excellence.

Key Responsibilities:

• Assist Facilities maintenance personnel in solving and repairing automated equipment and systems for which Facilities is responsible.
• Provide day-to-day administration of the BAS and EMS, including preventive maintenance, modification, change control, and compliance.
• Offer automation support for capital projects.
• Prepare, modify, review, and approve various documents, including SOPs, user requirement specifications, engineering/validation protocols, drawings, vendor submittals, and forms.
• Ensure compliance and active participation in all safety and environmental policies, procedures, and programs.
• Play a key role in the data integrity program, performing DI assessments of automated and manual equipment, and developing remediation plans as needed.
• Evaluate electronic record/electronic signature requirements per 21CFR part 11 compliance.
• Support global IT for network and IT issues for new projects and daily operations.
• Conduct investigations and root cause analyses for deviations and CAPAs concerning automated systems.
• Initiate and manage change controls for automated systems and equipment.
• Support the eDMS by performing site administrator functions.

Frequent Contacts:

Internal

• Manufacturing, Facilities, ADPD, Validation, Quality Assurance, and Quality Control departments

External

• Contractors and outside vendors

Requirements/Qualifications:

• Bachelor’s degree in a technical field such as computer science or engineering
• 10+ years of experience in a GMP environment
• Expertise with automated Building Monitoring Systems and Environmental Monitoring Systems
• Previous experience with 21 CFR part 11 compliance
• Background in WIN-911
• Proficiency with Windows-based PCs/Servers
• Strong technical skills, including problem-solving and basic PLC skills
• Ability to read, analyze, and interpret P&IDs, wiring diagrams, and common scientific and technical journals
• Excellent communication skills for responding to inquiries and complaints from customers, regulatory agencies, or members of the business community

Other Job Requirements:

• Alignment to OHS policies and procedures for a safe workplace
• Ability to move up to 25 lbs. and work in various environments
• Capacity to function in a dynamic setting and balance multiple priorities
• Willingness to work in a clean room environment with sterile gowning/PPE
• Availability for overtime as needed

Compensation and Benefits

The salary range estimated for this position based in California is $129,400.00–$165,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards