Contract, 3 months Automated Systems, Inc. United States
Posted On 09 / 17 / 2024
Job Information
Pharma / Biotech / Clinical Research
State / Province : Illinois
City : Gurnee
Zip Code : 60031
Job Description
Equipment Validation Engineer
Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered.
Gurnee, IL - ONSITE
Duration : 3 months minimum
Job Summary :
This position is responsible for development, execution, & analysis of validation projects to demonstrate facility, equipment, and process consistency and cGMP compliance for a sterile fill client.
Responsibilities include the generation and execution of IQ / OQ / PQ protocols and summary reports. The selected candidate will also collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches.
Other duties include providing validation project management associated with new or modified facilities; acting as interface between various functional areas (internal and external) to assure successful integration and completion of validation activities in overall project schedules.
All validation work will be in support of oral solid dose pharmaceutical manufacturing of tablets, capsules, and powders.
Expertise with the following equipment is desirable :
- Bottle Fillers
- Blister Fillers
- Labelers
- Uhlmann Thermoformers
Key Responsibilities :
- Responsible for development, execution & analysis of validation projects to demonstrate facility cGMP compliance.
- Author and execute IQ / OQ / PQ protocols for packaging equipment and operations.
- Author change controls, SOPs, and work instructions.
- Provide technical assistance to change controls / CAPAs, and deviations.
- Design and execute process and cleaning validation studies meeting site and industry standards.
- Assist with product changeovers, troubleshooting investigations, and continuous improvement initiatives.
- Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches.
Requirements
- A Bachelor’s of Science degree in Pharmacy, Engineering, or Science is required.
- 2+ years of experience in life sciences engineering is required.
- 1+ years of experience in validation is required.
- Experience working in FDA / cGMP compliant environment required.
- Strong collaboration, communication, and presentation skills required.
- Expert-level proficiency with Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
J-18808-Ljbffr
Quality Validation Engineer
The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and manage the execution of validations and creation of writt...
Validation Engineer - Temperature Mapping
The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. Initiate Change Controls - provide validation assessments and remediation plans as required by the. Bachelor&rsq...
Validation Engineer
As a Quality Validation Engineer, you'll play a pivotal role in ensuring the highest quality standards in the manufacturing of medical devices. Spearhead the planning, coordination, and execution of validation projects, ensuring seamless development and production of products that meet customer ...
Validation Engineer
As a Quality Validation Engineer, you'll play a pivotal role in ensuring the highest quality standards in the manufacturing of medical devices. Spearhead the planning, coordination, and execution of validation projects, ensuring seamless development and production of products that meet customer ...
Quality Engineer, Validation
The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. The Validation Engineer responsibilities may include: the review of commissioning and validation. Under the direction of the Validation Section Manager, this individual will participate in the im...
Validation Engineer
As a Quality Validation Engineer, you'll play a pivotal role in ensuring the highest quality standards in the manufacturing of medical devices. Spearhead the planning, coordination, and execution of validation projects, ensuring seamless development and production of products that meet customer and ...
Quality Validation Engineer
The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and manage the execution of validations and creation of writt...
Validation Engineer - Temperature Mapping
The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols, as well as Validation/Quali...
Quality Validation Engineer
The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and manage the execution of validations and creation of writt...
Validation Engineer - $95000.00 - $115000.00 / year
As a Quality Validation Engineer, you'll play a pivotal role in ensuring the highest quality standards in the manufacturing of medical devices. Spearhead the planning, coordination, and execution of validation projects, ensuring seamless development and production of products that meet customer ...