Engineer II, Computer Systems Validation
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Job Location:
Greenville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
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 facial hair etc... allowed OfficeJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges.
About the Business
Join our Pharma Services Group (PSG)a global leader providing integrated drug development and manufacturing solutions to pharmaceutical and biotech companies. Our Greenville North Carolina site specializes in sterile and oral solid dose (OSD) manufacturing supported by advanced technologies and a highly collaborative team environment.
Discover Impactful Work
As an Engineer II Computer Systems Validation (CSV) you will support validation activities tied to automation systems manufacturing equipment and computerized systems across the site. This role is primarily focused on change management and validation of existing commercial manufacturing systems ensuring compliance and operational readiness.
You will partner closely with automation manufacturing and quality teams to evaluate system changes determine validation requirements and execute qualification activities that maintain regulatory compliance and product quality.
A Day in the Life
- Evaluate changes to existing manufacturing systems equipment and related databases
- Support change management activities for commercial production lines
- Author and execute validation documentation including IQ/OQ/PQ protocols and qualification plans
- Perform risk assessments validation assessments and gap analyses to determine testing requirements
- Collaborate with automation and engineering teams to qualify system changes
- Support validation of automation and control systems (PLC SCADA DCS DeltaV etc.)
- Ensure compliance with cGMP FDA and industry standards
- Maintain accurate and compliant validation documentation
- Participate in continuous improvement and operational excellence initiatives
Work Schedule & Environment
- Standard schedule: MondayFriday 8:00 AM 5:00 PM
- Flexibility required to support off-hours work during shutdowns or system availability windows
- Fully onsite role in Greenville NC
- Work may occur in manufacturing or controlled environments as needed
Keys to Success
Education (Required)
- Bachelors degree in Engineering Life Sciences Chemistry or related technical field
Equivalency:
Equivalent combinations of education training and relevant experience may be considered in place of a degree
Experience (Preferred Not Required)
- Approximately 2 years of experience in validation CSV or a GMP-regulated environment
- Internship co-op or academic project experience in validation automation or regulated industries will also be considered
Knowledge Skills Abilities
- Foundational understanding of cGMP and regulated environments
- Exposure to Computer Systems Validation (CSV) CQV or automation validation
- Familiarity with automation/control systems (e.g. PLCs SCADA DCS DeltaV Allen-Bradley)
- Ability to support development of validation protocols (IQ/OQ/PQ)
- Strong technical writing and documentation skills
- Basic understanding of risk assessments and gap analysis
- Strong analytical and problem-solving skills
- Effective communication and collaboration skills
- Ability to manage multiple tasks in a fast-paced environment
- Proficiency with Microsoft Office tools
Preferred Qualifications
- Experience working with automation engineers or manufacturing systems
- Exposure to change management processes in regulated environments
- Familiarity with quality systems and validation lifecycle documentation
Competencies
- Detail-oriented
- Collaborative team player
- Adaptable and flexible
- Strong communicator
- Quality and compliance focused
Additional Information
- Role is primarily focused on Computer Systems Validation (CSV) with potential exposure to capital projects as business needs evolve
- This position is not expected to independently lead full-scale capital validation projects at this level
- Designed to support growth and development with guidance from experienced team members
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
