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Job Title: Engineer Senior, Biotech Process Development (JP12853)
Location: New Albany, OH
Business Unit: Final Product Technologies CORE (Combination Device)
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $40 - $45/hour
Posting Date: 06/12/2024
3 Key Consulting is hiring! We are recruiting an Engineer Senior, Process Development (Efor a consulting engagement with our direct client, a leading global biotechnology company.
Ideal candidate: Engineer or other technical background (mechanical, industrial, chemical…etc.). Experience leading technical projects from start to finish. supporting process development. Biotech, med device, or pharmaceuticals or other GMP manufacturing experiences preferred. Min. 3 years of experiences preferred. Candidate should showcase they have executed projects took ownership full lifecycle. Ideally smart sheets, MS Project, or other PM tools.
Job Description:
As a member of the team in Ohio, Process Development organization, this role serves as project manager for Final Drug Product New Process Introductions (NPI) into Ohio location. NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.
The Project Manager engages Final Drug Product development teams throughout the commercialization process, leading cross-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.
Primary responsibilities include assessment of NPI’s for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.
Top Must Have Skill Sets:
Project Management,
communication,
work in teams
Day to Day Responsibilities:
Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience
Red Flags:
Constant changing jobs.
Unwillingness to work onsite.
Unexplained gaps.
Interview Process:
First stage phone interview after screening resumes.
Second stage phone interviews with colleagues (1-3).
We invite qualified candidates to send your resume to resumes@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.
Location: New Albany, OH
Business Unit: Final Product Technologies CORE (Combination Device)
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $40 - $45/hour
Posting Date: 06/12/2024
3 Key Consulting is hiring! We are recruiting an Engineer Senior, Process Development (Efor a consulting engagement with our direct client, a leading global biotechnology company.
Ideal candidate: Engineer or other technical background (mechanical, industrial, chemical…etc.). Experience leading technical projects from start to finish. supporting process development. Biotech, med device, or pharmaceuticals or other GMP manufacturing experiences preferred. Min. 3 years of experiences preferred. Candidate should showcase they have executed projects took ownership full lifecycle. Ideally smart sheets, MS Project, or other PM tools.
Job Description:
As a member of the team in Ohio, Process Development organization, this role serves as project manager for Final Drug Product New Process Introductions (NPI) into Ohio location. NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.
The Project Manager engages Final Drug Product development teams throughout the commercialization process, leading cross-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.
Primary responsibilities include assessment of NPI’s for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.
Top Must Have Skill Sets:
Project Management,
communication,
work in teams
Day to Day Responsibilities:
- Work with various NPI support groups to develop, maintain, and execute the NPI project plan and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and escalation to various levels of management as appropriate.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
- Manage change control and coordinate with various functions to ensure success initiation, execution, and implementation of the change records.
- Familiar with project management tools (Smartsheet preferred) and proven records of successfully leading multiple projects at the same time.
Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience
Red Flags:
Constant changing jobs.
Unwillingness to work onsite.
Unexplained gaps.
Interview Process:
First stage phone interview after screening resumes.
Second stage phone interviews with colleagues (1-3).
We invite qualified candidates to send your resume to resumes@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.