Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)
Company: 3 Key Consulting
Location: New Albany
Posted on: April 2, 2026
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Job Description:
Job Title: Senior Packaging Validation Engineer, Biotech GMP
Final Drug Product (JP14454) Location: New Albany, Oh 43054
Business Unit: Site Process Development Employment Type: Contract
Duration: 2 years with possible extension or conversion to FTE Rate
: $53 - $63/hour (DOE) - W2 with benefits Posting Date: 8/28/2025.
3 Key Consulting is hiring! We are recruiting a Senior Validation
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/process The 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 Top Must
Have Skill Sets: packaging validation experience knowledge of
packaging equipment protocol generation and execution Day to Day
Responsibilities: writing and executing validation protocols. Value
proposition: Unique industry opportunity Networking Basic
Qualifications: Doctorate degree OR Masters degree and 2 years of
experience OR Bachelors degree and 4 years of experience OR
Associates degree and 8 years of experience Why is the Position
Open? Supplement additional workload on team Interview Process:
Initial screening with hiring manager Final interview panel with 3
interviewers We invite qualified candidates to send your resume to
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this particular position, please feel free
to take a look at the other positions on our website
www.3keyconsulting.com/careers. You are also welcome to share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Middletown , Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454), Engineering , New Albany, Ohio
