Senior Sterility Assurance Engineer
About The Position
This full-time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities. As a Senior Sterility Assurance Engineer you will define, execute, review/approve and summarize Aseptic Process Simulations, Cleaning Validation, Smoke Studies, Secondary Sterilization activities (eg EtO), etc. including investigations into failures. You will use quality engineering concepts to monitor, support, and critically review changes or issues to existing validated aseptic processes. This position is eligible for a hybrid work schedule, with up to 2 to 3 remote workdays per week based on business needs. Employees are expected to work on-site as required for meetings, client visits, audits, and other responsibilities that benefit from in-person collaboration and support.
Requirements
- BS in Engineering or Life Sciences
- 5-8 years of Sterility Assurance or Quality Engineering experience
- Experience with aseptic filling and cleaning validation.
Nice To Haves
- Background in pharmaceutical, biotechnology and/or chemistry production a strong plus!
Responsibilities
- Create and coordinate execution of sterility assurance and aseptic process validation protocols including but not limited to: Smoke studies, Media Fills, Steam sterilization, Secondary sterilization, Cleaning disinfectant efficacy
- Perform risk assessment (FMEA) on new/changed equipment and processes and procedures
- Provide knowledge leadership and technical expertise for validations and investigations
- Provide technical expertise in support of audits.
Benefits
- Opportunities to learn and grow with a well-respected company
- Competitive compensation with annual reviews and a company-wide incentive bonus
- 3 medical insurance plans to fit your needs and budget including an HSA Plan with company contributions.
- Low cost dental and vision insurance
- Short term disability, long term disability and life insurance all 100% company paid
- 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)
- 9 paid company holidays plus 2 personal holidays
- Paid family leave
- Tuition reimbursement
- 401k plan with company matching contribution
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What This Job Offers
Job Type
Full-time
Career Level
Senior
