3 Key Consulting, Inc. · 3 months ago
Senior Engineer, Biotech GMP New Line Packaging Operations (JP14555)
New Albany, Ohio
Full-time
Onsite
Mid, Senior Level
$65/hr - $85/hr
4+ years exp3 Key Consulting, Inc. is recruiting a Senior Engineer for a consulting engagement with a leading global biotechnology company. The Senior Engineer will own all technical aspects of a manufacturing line, focusing on process optimization, problem-solving, and providing direction to technical resources.
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Responsibilities
Provide solutions to a variety of technical problems of moderate scope and complexity
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems
Perform assignments that have clear and specific objectives and require investigation of limited number of variables
Initiate and complete routine technical tasks
Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications
Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints
Work with consultants, architects and engineering firms on development of standard design documents
Acquire and critique quotes for equipment modifications or installations
Generate rudimentary project cost estimates and schedules
Act as the equipment technical subject matter expert for an end to end pharmaceutical device assembly and packaging line
This individual is responsible for working with the maintenance and automation teams to resolve complex issues that are escalated beyond the technician level
This individual also leads improvement projects to increase line OEE
Qualification
Required
4+ YOE
Experience supporting a manufacturing line
GMP or regulated environment experience
Experience in a manufacturing environment, preferably GMP regulated or other highly regulated environment
Experience working hands-on to solve technical problems on manufacturing equipment
Great communication skills
Doctorate degree and 1+ years of experience OR Master's degree and 3+ years of experience OR Bachelors degree and 5 years of experience OR Associates degree and 8 years of experience
Preferred
Relevant pharma experience
Experience starting up a new manufacturing line
Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
Knowledge of pharmaceutical/biotech processes
Familiarity with validation processes for Packaging areas
Familiarity with serialization process and networking
Familiarity with documentation in a highly regulated environment
Ability to operate specialized equipment, tools and computers as appropriate
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
Ability to apply engineering science to production
Able to develop solutions to routine technical problems of limited scope
Comprehensive understanding of protocol requirements
Organizational, project management, problem-solving, as well as validation protocol
Technical writing capability
Excellent communication (verbal/written) and presentation skills
Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
Protocol and script testing Writing
Dealing with and handling change
Packaging Equipment Technical knowledge
Analytical Problem Solving
Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context
Benefits
W2 with benefits
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
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