Aseptic Process Engineer

Job Posted 25 Days Ago Posted 25 Days Ago
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Italy
Hybrid
Mid level
Healthtech • Pharmaceutical
The Role
The Aseptic Process Engineer ensures sterility assurance and oversees aseptic process simulation, contamination control, and validation strategies in a regulated environment.
Summary Generated by Built In

Requested skills: Support Sterility Assurance assessment in regulated manufacturing industry. Experience in Environmental qualification and Contamination control Strategy. Experience in aseptic process simulation risk assessment, validation strategy and oversight. Experience in Contamination control strategy of pharmaceutical sterile products. Execution of sterilizing equipment qualification. Experience in microbiological and biological method application and validation. Participates in cross functional projects, including customer meetings. Participates in the writing of protocols, reports, and specifications. Drives deliverables to completion with structured timelines. Requested Qualifications: Degree in microbiology, biology, biotechnology or science-related field Understanding of good documentation practices and general quality laboratory function. Ability to work independently. Strong attention to details, organizational skills and drive to be successful. Experience with aseptic technique and biological safety cabinets. Essential: Proficient in spoken and written English and /or a native language

Able to travel domestically and internationally if required

Top Skills

Aseptic Techniques
Contamination Control Strategies
Sterilization Equipment
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The Company
HQ: Indianapolis, IN
923 Employees
On-site Workplace
Year Founded: 1996

What We Do

Fundamentally we exist for one reason: To be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

We are 800+ global experts that bring top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to eliminating that last punch list item and beyond, into rigorous asset management, reliability, and sustainability activities. We are your choice regardless of your location.

Philosophically and practically, we believe that quality, cost, and schedule can be mutually reinforcing – trade-offs are not necessary. Short-changing the focus on quality usually means problems down the road – problems that can cost money and delay the schedule. But if quality is built in from the start, then both project delivery and operational efficiency can be achieved with a much higher degree of assurance.

When your project requires planned, managed, and documented high quality to exacting global standards. When you need high-performance teams on mission-critical projects. When your project is complex, high-visibility, and carries significant risk. We can help you meet a higher standard.

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