Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)
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Overview
Career level
Senior-level
Remote
On-site
Compensation
$53-$63/hour
Benefits
Health Insurance
Job Description
Job Title: SeniorPackagingValidation Engineer, Biotech GMP Final Drug Product (JP14454)Location: New Albany, Oh 43054Business Unit: Site Process DevelopmentEmployment Type: ContractDuration: 2+ years with possible extension or conversion to FTERate: $53 - $63/hour (DOE) - W2 with benefitsPosting Date: 8/28/2025.3 Key Consulting is hiring! We are recruiting a SeniorValidation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.The Senior Validation Engineer position reports into the Sr. Manager of Validation. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations. Location Options: 100% Site Presence Required. The position is expected to travel for approximately 10%.Job Description & Responsibilities:The Senior Validation Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise (characterization, validation and troubleshooting) in the validation of combination products. This position also requires the application of advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process optimization, scale up and manufacturing support projects.Output: Key responsibilities will include supporting the packaging C&Q activities of the product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advisory of technical improvement projects. The Sr. Validation Engineer must ensure effective communication throughout the Ohio commercial site and network with all stakeholders and deliver on technical deliverables.Relationship: The Senior Validation Engineering is expected to build on the network expertise across the company commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/processThe successful candidate will have:
- Knowledge of high-speed, highly automated secondary packaging operations
- Knowledge of the validation of equipment such as PFS assembly, cartoners, vision systems
- Experience in writing protocols
- Experience in executing protocols
- Capable of executing multiple projects
- Communication skills and ability to work with other people
- Bring innovative solutions for continuous process improvement
- Experience with Kneat
- Experience with MiniTab is a plus*
- packaging validation experience
- knowledge of packaging equipment
- protocol generation and execution*
- writing and executing validation protocols.
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FAQs About Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454) Jobs at 3 Key Consulting
What is the work location for this position at 3 Key Consulting?
This job at 3 Key Consulting is located in New Albany, Ohio, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at 3 Key Consulting?
Candidates can expect a pay range of $53–$63 per hour for this role.
What employment applies to this position at 3 Key Consulting?
The employer has not provided this information. This may be discussed during the hiring process.
What experience level is required for this role at 3 Key Consulting?
3 Key Consulting is looking for a candidate with "Senior-level" experience level.
What benefits are offered by 3 Key Consulting for this role?
3 Key Consulting offers Health Insurance for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at 3 Key Consulting?
You can apply for this role at 3 Key Consulting either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.