Validation Engineer III
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Job Location:
Bothell, WA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company in Bothell WA is currently looking for a Equipment Validation Engineer to join their expanding team.
Job Title: Equipment Validation Engineer / Pharma Industry
Duration: 9 months contract extendable up to 48 months
Location: Bothell WA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Our client a world-leading Pharmaceutical Company in Bothell WA is currently looking for a Equipment Validation Engineer to join their expanding team.
Job Title: Equipment Validation Engineer / Pharma Industry
Duration: 9 months contract extendable up to 48 months
Location: Bothell WA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Validation Engineer III
Manager provided responsibilities for the role.
1. Provide lifecycle management for Quality Control lab instruments and related software systems.
2. Revise and/or obsolete validation documents and Standard Operating Procedures (SOPs).
3. Provide validation services for laboratory analytical instruments and controlled temperature units (CTU) to include writing editing executing protocols and reviewing vendor validation documents in accordance with site requirements for validation activities.
4. Perform change control management activities: authoring performing and tracking of change actions
5. Creating and performing investigations for Deviations/CAPAs
6. Perform instrument periodic reviews
7. Escort onsite vendors performing laboratory instrument maintenance
1. Provide lifecycle management for Quality Control lab instruments and related software systems.
2. Revise and/or obsolete validation documents and Standard Operating Procedures (SOPs).
3. Provide validation services for laboratory analytical instruments and controlled temperature units (CTU) to include writing editing executing protocols and reviewing vendor validation documents in accordance with site requirements for validation activities.
4. Perform change control management activities: authoring performing and tracking of change actions
5. Creating and performing investigations for Deviations/CAPAs
6. Perform instrument periodic reviews
7. Escort onsite vendors performing laboratory instrument maintenance
Summary:
The main function of a Validation Engineer is to ensure that systems equipment and processes meet regulatory and performance standards through rigorous testing and documentation.
A typical Validation Engineer develops protocols executes validation activities and supports compliance across manufacturing or research environments.
The main function of a Validation Engineer is to ensure that systems equipment and processes meet regulatory and performance standards through rigorous testing and documentation.
A typical Validation Engineer develops protocols executes validation activities and supports compliance across manufacturing or research environments.
Job Responsibilities:
Design and execute validation protocols (IQ/OQ/PQ) for equipment utilities and processes
Analyze test data and determine whether systems meet predefined acceptance criteria
Document validation activities and maintain records in accordance with regulatory guidelines
Collaborate with cross-functional teams to support product development and process improvements Investigate deviations and implement corrective and preventive actions (CAPAs)
Ensure compliance with industry standards such as FDA ISO and cGMP Participate in audits and inspections providing validation documentation and responses
Stay current with validation trends technologies and regulatory updates
Design and execute validation protocols (IQ/OQ/PQ) for equipment utilities and processes
Analyze test data and determine whether systems meet predefined acceptance criteria
Document validation activities and maintain records in accordance with regulatory guidelines
Collaborate with cross-functional teams to support product development and process improvements Investigate deviations and implement corrective and preventive actions (CAPAs)
Ensure compliance with industry standards such as FDA ISO and cGMP Participate in audits and inspections providing validation documentation and responses
Stay current with validation trends technologies and regulatory updates
Skills:
Strong analytical and problem-solving abilities
Knowledge of validation principles quality systems and regulatory requirements
Proficiency in statistical analysis tools and validation software
Excellent written and verbal communication skills
Ability to work independently and manage multiple projects
Familiarity with laboratory and manufacturing environments
Strong analytical and problem-solving abilities
Knowledge of validation principles quality systems and regulatory requirements
Proficiency in statistical analysis tools and validation software
Excellent written and verbal communication skills
Ability to work independently and manage multiple projects
Familiarity with laboratory and manufacturing environments
Education/Experience:
Bachelors degree in Engineering Life Sciences or a related field required
5-7 years of experience in validation quality assurance or process engineering
Bachelors degree in Engineering Life Sciences or a related field required
5-7 years of experience in validation quality assurance or process engineering
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
