Senior Software Engineer, Behavior Validation
General MotorsSalary not specified
Full Time
Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Biotechnology, Life SciencesIndustries
Requirements
- Four-year Bachelor of Science degree from an accredited college or university in an Engineering or Science field
- 2-5 years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experience
- Knowledge of Computer System Validation (CSV)
- Knowledge of Controlled Temperature Unit Operation and Management
- PC literacy including the ability to generate sophisticated documents in both Microsoft Excel and Microsoft Word
- Strong analytical skills
- Capable of multitasking and responding to shifting priorities
- Good communication skills, both written and verbal
- Results oriented
- Prior mechanical and process equipment experience
- Able to lift 40 lbs. without assistance
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Full-time onsite presence at Frederick, MD location
Responsibilities
- Preparation and execution of validation documentation (VP, IQ, OQ, PQ) and generation of corresponding summary reports
- Support the generation of Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and PPQ
- Generate, complete, and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipment
- Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities
- Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices)
- Analyze the results of testing and resolve acceptability of results against pre-determined criteria
- Identify protocol discrepancies from established product or process standards and provide recommendations for resolving them
- Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols
- Coordinate with other departments or outside contractors/vendors to complete validation tasks
- Demonstrate and promote the company vision of the 4 I’s: Integrity, Intensity, Innovation and Involvement
- Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum
- Conduct all activities in a safe and efficient manner
- Other duties may be assigned to meet business needs
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this position remote or onsite?
This role requires full-time onsite presence at the Frederick, MD location.
What are the main responsibilities of the Validation Engineer III?
Responsibilities include preparing and executing validation documentation (VP, IQ, OQ, PQ), generating PPQ documentation, performing risk assessments, conducting work according to SOPs and cGMPs, analyzing test results, and coordinating with other departments.
What is the salary range for this Validation Engineer III position?
This information is not specified in the job description.
What is the company culture like at Thermo Fisher Scientific?
The company promotes the 4 I’s: Integrity, Intensity, Innovation, and Involvement, with a mission to make the world healthier, cleaner, and safer through a distributed team of over 3,500 employees in 15+ countries.
What qualifications make a strong candidate for this role?
Strong candidates will have expertise in validation documentation (VP, IQ, OQ, PQ), PPQ processes, risk assessment, cGMP compliance, and experience coordinating across departments in a pharmaceutical or biotech environment.
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees