Sterility Assurance Project Manager

Reporting to the Global Director of Sterility Assurance, you will be responsible for EO and Radiation sterilization projects, process maintenance and support for several of my client's manufacturing sites. You will perform sterilization evaluations and/or validations for products transitions, new products, products' modification and products' introduction to new markets.

Major duties include:

* Maintain EO sterilization Master Validation Plan for 3 separate manufacturing facilities.
* Prepare EO sterilization annual re-validation reports for products' sterilization cycles.
* Maintain Quality systems and establish validaton sterilization procedures in compliance to FDA regs and ISO requirements.
* Represent SA for sterilization evaluations and/or validations of clients projects: product transitions, new products, existing product improvement and new market introductions.
* Maintain sterilization related procedures current per relevant domestic and International standards.
* Develop and maintain sterilization product adoption database for products to be used and reference in products' evaluations.
* Maintain contact and able to negotiate with sterilization, laboratory and consultant suppliers.
* Work closely with departments such as R&D, marketing, and RA in understanding, developing and executing statistically designed experiments, validations, technical reviews and reports, as required,m for products' transitions, new products, products' modifications and new market introductions.
* Assist in supplier and/or plants' quality assessments, as required.
* Complete special projects as directed by Global Director SA.
REQUIREMENTS
* Knowledge and experience in Sterilization validation and product adoption (specially EO and gamma radiation).
* Proven project management skills.
* Regulatory, cGMP, QSR, Sterilization related to ISO and EN Standards and relevant sterilization AANI TIR, knowledge base.
* Statistical knowledge (DOE, SPC, Hypothesis testing, Sample Comparison).
* Computer literate
* Negotiation and problem solving skills
* Ability to operate and communicate effectively with multiple teams.
* Supplier auditing skills (CQA preferred)
* BS degree in a Scientific field (Microbiology, Biology, or similar)
* Minimum eight years experience in EO sterilization routine and validation processes.
* Experience in multiple projects handling and management.
* Skillful technical writer.

Send resume as a MS Word attachment along with salary requirements.