3 Key Consulting, Inc.

Engineer Senior, Biotech Process Development (JP12853)

3 Key Consulting, Inc.  •  $40 - $45/hr  •  New Albany, OH (Onsite)  •  16 days ago
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Job Description

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.


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.
3 Key Consulting, Inc.

About 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. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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