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Engineer Senior, Biotech Primary Containers, Sterilization - Remote (JP10541)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer Senior, Biotech Primary Containers, Sterilization - REMOTE (JP10541)
Location: Thousand Oaks, CA. (100% remote position)
Employment Type: Contract
Business Unit: Primary Container Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 7/13/22
Notes: Only qualified candidates need apply. REMOTE - Working in EST would preferable but not required
3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
This position will operate in a highly matrixed environment and collaborate with cross functional teams, communicate, and elevate technical or strategic issues to team members and management and make recommendations and/or decisions to guide successful execution of process transfers.
Top Must Have Skills:
Day to Day Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Less than 2-4 years’ experience in device sterilization
Interview process:
Video Skype Panel Interview
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: Thousand Oaks, CA. (100% remote position)
Employment Type: Contract
Business Unit: Primary Container Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 7/13/22
Notes: Only qualified candidates need apply. REMOTE - Working in EST would preferable but not required
3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
- The Senior Engineer position reports into Final Product Technology in Thousand Oaks.
- This position requires the application of diverse and advanced engineering principles (mechanical and materials science), as well as excellent project management and communication skills.
- Key job responsibilities are design, optimize, characterize, and troubleshoot the deployment of primary container systems/platforms and combination products in a GMP aseptic environment.
- Lead primary component technical activities within Process Development and external partners
- Determine User Requirement Specifications of primary container closure systems for new and existing client products
- Provide hands-on technical leadership on primary component issues related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals
- Support development of characterization methods for mechanical and physical properties of primary components
- Support integration of primary containers into new and existing devices
- Support on-going Deviations/CAPAs and Change Control
This position will operate in a highly matrixed environment and collaborate with cross functional teams, communicate, and elevate technical or strategic issues to team members and management and make recommendations and/or decisions to guide successful execution of process transfers.
Top Must Have Skills:
- Experience in assessing sterilization process issues.
- Validation - able to come up with good solutions and strategies as it relates.
- Strong technical writing experience
Day to Day Responsibilities:
- Writing and reviewing technical sterilization protocols, reports and assessments.
- Supporting project execution activities, leading meetings and supporting key decisions for validation and process development strategies.
Basic Qualifications:
- Doctorate degree OR
- Master’s degree and 3 years of Engineering or Life Sciences experience OR
- Bachelor’s degree and 5 years of Engineering or Life Sciences experience OR
- Associate’s degree and 10 years of Engineering or Life Sciences experience OR
- High school diploma / GED and 12 years of Engineering or Life Sciences experience
Preferred Qualifications:
- M.S. or Ph. D. in Materials Science, Chemical Engineering or Mechanical engineering
- 3+ years of experience in the Pharmaceutical/Biotechnology industry
- Aseptic fill/finish experience
- Experience with the manufacturing process of primary container systems (glass/elastomers/polymers) for medical (aseptic) applications
- Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
- Work history with cGMPs, regulatory filings and compliance issues for oral dosage forms (solid and liquid)
- Excellent written and verbal communication experience combined with demonstrated ability to work in a team environment
- Project management experience including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects
- Experience including statistical analysis and design of experiments, process characterization, scale-up, and/or technology transfer
- Experience leading, deploying or using Operational Excellence principles and tools (eg. HRP, Lean Six Sigma etc.)
- Ability to travel to international locations assisting our development partners during implementation of specific container requirements into their processes
Less than 2-4 years’ experience in device sterilization
Interview process:
Video Skype Panel Interview
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.
Regards,
3KC Talent Acquisition Team