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Engineer, Medical Device Gas Sterilization Process Validation - Remote (JP12324)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer, Medical Device Gas Sterilization Process Validation - (JP12324)
Location: 100% REMOTE
Business Unit: Primary Container Engineering
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $36 - $42
Posting Date: 2/29/24
Notes: Only qualified candidates need apply. Fully remote with preference to for EST hours.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for client’s portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
Interview Process:
One phone and one virtual 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: 100% REMOTE
Business Unit: Primary Container Engineering
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $36 - $42
Posting Date: 2/29/24
Notes: Only qualified candidates need apply. Fully remote with preference to for EST hours.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for client’s portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.
Top Must Have Skill Sets:
- 2+ years experience in gas sterilization process validation/ requalification's and sterility assurance microbiology
- strong technical writing skills and strong communication skills
- ISO 14937, ISO 11135
- sterilization
- validation
- microbiology
Day to Day Responsibilities:
- support/ lead process development and commercialization of gas sterilization processes of combination products
- coordinate manufacturing site requirements to support sterilization requirements
- support the design control process and qualification of primary components
- support tech transfer projects for combination products
- develop specs of primary container closure systems for new and existing client products
- support the development and operational improvements with key primary component suppliers
- support development of characterization methods for mechanical and physical properties of primary components
- support on-going deviation/ CAPA and change control
- Support/ lead client supplier/ raw materials sterility assurance assessments
- collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
- Drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences
Basic Qualifications:
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- 2+ years experience in gas sterilization process validation/ requalification's and sterility assurance microbiology
- strong technical writing skills***
- ISO 14937, ISO 11135
Preferred Qualifications:
- 8+ years in ethylene oxide or other gas sterilization processes
- 2+ years industry experience in sterility assurance of combination products
- 5+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilization
- Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
- Strong problem-solving skills
- Capability to advance multiple projects in a fast paced environment
- Strong oral and written communication skills, decision making, presentation, and organization skills
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
- Candidate must have gas sterilization background- radiation only is not sufficient.
- Gas sterilization includes ethylene oxide (EO), steam, dry heat, vaporized hydrogen peroxide, nitrogen dioxide
Interview Process:
One phone and one virtual 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