Location: Anasco, PR

Summary:
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.

Requirements:

• Must have expertise in one or more of the following areas:
  • Ethylene oxide sterilization validation and re-qualification.
  • 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.

Qualifications:

• Bachelor’s degree in Engineering, Microbiology, or a similar discipline.
• Minimum of 7 years of experience in the medical device and/or pharmaceutical manufacturing environment.
• Effective experience and knowledge in sterilization processes.
• Excellent organizational and communication skills.
• Results-oriented with a strong focus on quality principles.
• Excellent technical writing skills with an understanding of good documentation practices.
• Develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical/Investigation Reports, SOPs, etc.
• Experience conducting microbial test method validations and managing projects independently.
• Experience creating and changing procedures 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.
• Fully bilingual (English and Spanish).

Knowledge of Standards:

• 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, USP.
• Working knowledge of applicable regulations and their interpretation within industry.

Project Management Skills:

• Knowledge in Project Management skills.
• Proficiency in Microsoft Project software.
• Ability to track milestones and manage projects.

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers health benefits that include vision, dental, and pharmacy. Additional benefits offered to eligible employees include a 401K retirement plan with employer matching, a referral bonus program, and an EAP (Employee Assistance Program). SPECTRAFORCE provides unpaid leave as well as paid sick leave and vacation when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at benefits_pr@spectraforce.com if you require reasonable accommodation. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $33.92/hr.