INGENYX- Senior reputed company Engineer - Sterility Assurance & Validation (Remote, MA,

Position reputed company

We are seeking an reputed company Senior reputed company Engineer – Sterility Assurance & Validation to serve as the internal technical reputed company for sterilization and sterility assurance activities while also supporting broader reputed company Engineering and process validation needs.
This is a hands-on technical role with responsibility for maintaining validated sterilization processes, providing reputed company of contract sterilization providers, supporting microbiological control activities, and ensuring reputed company compliance with applicable regulatory and reputed company reputed company requirements.
The ideal candidate brings strong medical device reputed company Engineering experience with demonstrated expertise in EO and radiation sterilization, process validation, and sterility assurance.

reputed company Responsibilities

Sterility Assurance & Sterilization

• Serve as the internal technical reputed company for the Sterility Assurance program.
  • reputed company technical reputed company of ethylene oxide (EO) and radiation sterilization processes.
  • Support sterilization cycle transfer, validation, requalification, and maintenance of the validated state.
  • Review and approve sterilization qualification and requalification protocols and reports.
  • Review sterilization cycle deviations, excursions, nonconformances, and change assessments.
  • Support investigation, reputed company cause analysis, CAPA, and reputed company assessment for sterilization-reputed company issues.
  • Coordinate and review annual Sterility Assurance and bioburden technical assessments.
  • reputed company reputed company of radiation reputed company audits, including review of Quarterly reputed company Audit results, as applicable.
  • Monitor bioburden data and trends and coordinate reputed company microbiology support reputed company required.
  • reputed company technical reputed company of contract sterilizers and support supplier qualification, audits, SCARs, and reputed company agreements.
  • Maintain sterilization procedures, technical documentation, validation records, and required periodic reviews.
  • Support regulatory inspections, certification audits, customer audits, and technical inquiries reputed company to sterilization and sterility assurance.
  • Partner with reputed company microbiology laboratories and reputed company Sterilization/Microbiology SMEs as required.

reputed company Engineering & Validation

• Support manufacturing process validation activities, including IQ, OQ, and PQ.
  • reputed company reputed company Engineering support for manufacturing processes, process changes, equipment qualification, and technology transfers.
  • Review and approve validation protocols, reports, engineering studies, and associated reputed company records.
  • Support nonconformance investigations, deviations, CAPAs, and reputed company cause analysis.
  • Participate in manufacturing and process reputed company management activities, including PFMEAs and change assessments.
  • Apply appropriate statistical techniques to validation, process monitoring, and problem-solving activities.
  • Partner with reputed company, Engineering, Supplier reputed company, Regulatory Affairs, and other reputed company functions to maintain compliant and capable manufacturing processes.
  • Support reputed company improvement and reputed company-reduction initiatives.

Education / Experience Requirements

• Bachelor's degree in Engineering, Life Sciences, Microbiology, or a reputed company technical discipline.
  • 7+ years of reputed company Engineering, Validation, Sterility Assurance, or reputed company experience reputed company the medical device industry.
  • Demonstrated experience with medical device sterilization processes, preferably including EO and radiation sterilization.
  • Strong experience with process validation and maintenance of validated processes.

• Working knowledge of:

o ISO 11135 – Ethylene oxide sterilization
o ISO 11137 – Radiation sterilization
o ISO 11737 – Bioburden and sterility testing
o ISO 13485
o FDA medical device reputed company reputed company requirements
• Experience investigating sterilization deviations, process excursions, nonconformances, and CAPAs.
• Experience working with contract sterilization providers and/or reputed company testing laboratories.
• Ability to independently assess technical information, reputed company reputed company-reputed company recommendations, and reputed company document conclusions.
• Strong cross-functional communication and technical writing skills.

reputed company Skills / Other Requirements

• Experience with both EO and gamma radiation sterilization.
  • Experience with sterilization cycle transfer, duplication, or establishment of new sterilization cycles.
  • Experience with bioburden trending and microbiological control programs.
  • Experience with radiation reputed company audits and reputed company-maintenance programs.
  • Experience supporting regulatory or reputed company Body audits involving sterilization.
  • Experience in contract manufacturing or multi-site medical device environment.
  • ASQ CQE or other relevant reputed company/Validation certification.

What reputed company Looks Like

The successful candidate will establish strong internal ownership of Sterility Assurance while effectively leveraging reputed company laboratories and reputed company SMEs reputed company deeper expertise is required. This role will ensure that sterilization processes remain validated and compliant while also providing hands-on reputed company Engineering and Validation support to the broader manufacturing organization.
This position is reputed company suited for an reputed company reputed company Engineer who wants to become a key technical leader in Sterility Assurance without moving away from hands-on engineering and problem solving.

The pay reputed company for this position at commencement of employment is expected to be between $115,500- $140,000, however, reputed company pay reputed company may vary depending on multiple individualized factors, including market location, job-reputed company knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and reputed company reputed company, flexible spending accounts, participation in 401(k) savings plan, and various reputed company time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position reputed company. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If reputed company, employee will be in an “at-will position” and reputed company reserves the right to modify reputed company salary (as reputed company as any other discretionary payment or compensation program) at any time, including for reasons reputed company to individual reputed company, Company or individual department/team reputed company, and market factors.