Lead Automation Systems Engineer
Lead Automation Systems Engineer
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$ 129400 - 165000
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 worldclass 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 daytoday 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:
- Bachelors 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 WIN911
- Proficiency with Windowsbased PCs/Servers
- Strong technical skills including problemsolving 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 $129400.00$165000.00.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 longterm 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
Employment Type
Full-Time
Key Skills
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