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Sterilization Project Validation Specialist III
MINIMUM QUALIFICATIONS
We are looking a SME in sterilization with solid background in validations and sterilization cycle changes. In addition, the resource needs to have excellent project management and communication skills to support the project program governance.
SUMMARY DESCRIPTION:
This job description is designed to outline the primary functions and qualifications of this position.
The incumbent is responsible for providing support to Corporate / Division Sterilization Workstream to ensure efficient and timely completion of project deliverables related to sterilization area including, but not limited to new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements, among others.
Responsibilities associated with this position include working with sites interpreting microbiological testing data, monitoring, and maintaining the sterility assurance used in medical device manufacturing. The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
The candidate must be a senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate.
The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment.
Qualified candidates must possess relevant experience in one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below.
Ethylene oxide sterilization validation and requalification
Bacterial endotoxin test method validation and monitoring
Bioburden test method validation and monitoring
Reusable Medical Devices
Radiation sterilization validation and dose audit management
Controlled environment monitoring
Knowledge, skills, and abilities:
Demonstrates excellent organizational and communication skills.
Results oriented with a strong focus on quality principles.
Excellent technical writing skills with an understanding of good documentation practice. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Solid background in sterilization validations.
Experience conducting microbial test method validations and managing projects independently.
Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.
Experience with controlled environment monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization and dose audit management.
Working knowledge of applicable microbiology standards including, but not limited to, FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, CMDR, Medical Device Directive, European Medical Device Regulation and USP.
Working knowledge of applicable regulations and their interpretation within industry.
Knowledge in Project Management skills and Microsoft Project software.
Ability to track milestones and manage projects.
Fully bilingual (English and Spanish)
Education an Experience:
Bachelor’s degree in Engineering, Microbiology or similar discipline.
Minimum of 15 years of experience in the medical device and/or pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes.
**CANDIDATE MUST LIVE IN PUERTO RICO**
Job Types: Full-time, Contract
Pay: $85,000.00 - $110,000.00 per year
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Application Question(s):
Do you possess relevant experience in one or more of the following areas:
>Ethylene oxide sterilization validation and requalification
>Bacterial endotoxin test method validation and monitoring
>Bioburden test method validation and monitoring
>Reusable Medical Devices
>Radiation sterilization validation and dose audit management
>Controlled environment monitoring
Are you a subject matter expert (SME) with over 5 years of experiences in sterilization with solid background in validations and sterilization cycle changes?
Experience:
Sterilization: 5 years (Required)
Work Location: In person
Project Validation Specialist III - Packaging Requalification Program
Project Validation Specialist III - Packaging Requalification Program
Summary Description:
The position is to support the Anasco Packaging Requalification Program at Client's site at Añasco, PR. The incumbent will be supporting the following activities to ensure conformance with ISO 11607 for all SKU’s packaged at Client's site at Añasco, PR.
Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
Document Generation – Generate all documentation required, included but not limited to Change Control, Validation Protocols, Drawings, Routers, etc identified as required as part of the project needs.
Validation Executions – Participate in the validation activities (IQ, OQ, PQ, Shipping and Shelf Life, TMV etc.) required to ensure compliance with ISO 11607 as part of the project deliverables.
The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.
MINIMUM QUALIFICATIONS on Knowledge, skills, and abilities:
Must have knowledge of ISO 11607 regulations for sterile barrier packaging.
Must have a thorough understanding of packaging and transit (transport) testing and performance test methods (conditioning, compression testing, drop testing, vibration testing, bubble leak test, among others).
Must have knowledge in shelf-life validation (aging studies), sterile barrier sealing process validation and packaging validation.
Must have knowledge and working experience in package and sealing integrity tests as well as package seal strength tests such as: seal strength (peel) test, burst test, creep test, bubble leak test and dye penetration, among others.
Must have a solid understanding of packaging materials, capabilities, and equipment.
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Proficiency in usage of Minitab and equivalent tools to perform advanced statistical analysis.
Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Must have excellent communication skills and a strong track record of working cross-functionally.
Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving.
Teamwork oriented and self-starter.
Fully bilingual (English and Spanish).
Availability to work extended hours in a day and weekends as required.
Education and/or experience:
BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
Hands-on experience with ISO11607 remediation projects, compliance projects, process validation and/or packaging validation projects required.
Experience with managing documents within electronic PLM system.
Experience with working with cross functional team.
Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.
Other Requirements:
**CANDIDATE MUST LIVE IN PUERTO RICO**
No relocation nor travel expenses.
Job Types: Full-time, Contract
Pay: $85,000.00 - $110,000.00 per year
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Work Location: In person
Validation Specialist III - EUMDR
JOB Summary Description:
The Validation Specialist III position will support the European Union Medical Device Regulation (EU MDR) program at our Top Client located at Añasco, PR.
MINIMUM QUALIFICATIONS
The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at our client site, included in the EU MDR program.
Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
Gap Assessments – Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
Remediation Plan – Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update through site change orders system.
Requirements:
Bachelor's degree in Chemical Engineering, Industrial Engineering, Mechanical Engineering, Biotechnology or related sciences.
Minimum of 5 years of EUMDR program, Data Gathering, Gap Assessments and/or Remediation Plan experiences in the LifeScience and/or medical device industry.
Other Requirements:
**CANDIDATE MUST LIVE IN PUERTO RICO**
No relocation nor travel expenses.
Job Types: Full-time, Contract
Pay: $90,000.00 - $120,000.00 per year
Schedule:
8 hour shift
Day shift
Monday to Friday
Work Location: In person
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