3 Engineer Senior, Biotech Primary Containers, Sterilization - Remote (JP10541) Jobs in Thousand Oaks, CA

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Engineer Senior, Biotech Primary Containers, Sterilization - Remote (JP10541)

3 Key Consulting

Thousand Oaks, CA | Full Time

$98k-119k (estimate)

6 Months Ago

Engineer, Medical Device Gas Sterilization Process Validation - Remote (JP12324)

3 Key Consulting

Thousand Oaks, CA | Full Time

$105k-127k (estimate)

2 Months Ago

Human Factors Engineer, Biotech Medical Device - REMOTE (JP11933)

3 Key Consulting

Thousand Oaks, CA | Full Time

$113k-137k (estimate)

6 Months Ago

Engineer Senior, Biotech Primary Containers, Sterilization - Remote (JP10541)

3 Key Consulting Thousand Oaks, CA

$98k-119k (estimate)

Full Time | Business Services 6 Months Ago

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3 Key Consulting is Hiring a Remote Engineer Senior, Biotech Primary Containers, Sterilization - Remote (JP10541)

Job Title: Engineer Senior, Biotech Primary Containers, Sterilization - REMOTE (JP10541)Location: Thousand Oaks, CA. (100% remote position)Employment Type: ContractBusiness Unit: Primary Container EngineeringDuration: 1 years (with likely extensions and/or conversion to permanent)Posting Date: 7/13/22Notes: Only qualified candidates need apply. REMOTE - Working in EST would preferable but not required3 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

Red Flags:Less than 2-4 years’ experience in device sterilizationInterview 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.