Seniority

Minimum 3 Years

Job functions

Process Engineering, Validation, Technical Support

Employment type

NNE employee

Department

US Operations

Location

As Validation Consultant, you'll be working with a motivated, multi-disciplinary team where, you'll be:

• Participate in the validation of bulk process equipment
• Take the lead on several validation tasks such as concept development, design review, supplier assessments, FAT, SAT, qualification, PQ, etc. underneath the umbrella of Science and Risk Based Validation (SRV)
• Prepare, execute, review documentation in all project phases (i.e. IOQ, IOV, PQ, and PV)
• Provide validation and/or technical support on FAT, SAT, and start up activities of process equipment
• Prepare risk assessments and work collaboratively with stakeholders and impacted groups

At NNE, we care about who you are as a person. Essentially, how you work, and your energy, is what impacts the work we do as a team. As a person, you:

• Focus on quality with a basic interest in validation and combining it with your process knowledge
• Have solid customer orientation skills and take part in building customer relationships
• Are able to work independently with precision and are labeled a “self starter”
• Are agile and able to prioritize urgent tasks and collaborate on team projects

To apply for the position there are some things that are needed, and others are a bonus. We believe these qualifications are needed for you to do well in this role:

• B.S. or M.S. in Chemical Engineering or similar field
• 3-5 years hands-on experience with creating and executing equipment commissioning and validation including IQ/OQ/PQ
• Experience with sterile filling technology (isolators, fillers, cappers, classified rooms, product/equipment sterilizers, compounding and formulation)
• Experience with bulk and downstream processes
• Direct experience with eTIMS preferred