Role: Quality Assurances Engineer
Location: Elwood, KS
Duration: Long Term

Job Responsibilities:

• Provide Quality Assurance oversight for the execution, commissioning, qualification, and validation activities for major projects. This may include, but is not limited to; Factory Acceptance Testing, construction oversight, execution of onsite commissioning and qualification activities, support for process validation, etc.
• Ensure execution of capital projects considering USDA and EMA regulatory and quality requirements.
• Review relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, validation plans/protocols, etc.
• Escalate protocol departures of a critical nature and ensure issues are addressed and remediated accordingly
• Provide technical consultation and interpretation of local procedures, corporate standards, and regulatory expectations.
• Demonstrate strict adherence to relevant local, state, and federal requirements, cGMP standards, and Elanco policies and procedures. Exemplify the "Safety First and Quality Always" mindset.

Basic Requirements:

• Bachelor of Science degree in Engineering or related fields
• 3+ years supporting cGMP manufacturing?

Additional Skills & Qualifications:

• Must have experience in computer system validation (CSV) and equipment validation, with a strong background in pharma regulations and EU compliance standards.
• Prior experience in C&Q, CQV, and CSV is preferred, along with proficiency in Microsoft Office and electronic document management systems (e.g., Veeva).
• Responsibilities include IOQ protocol generation, SOP writing, and oversight of audit trails during a major pharmaceutical site upgrade.
• Candidates should possess excellent technical writing skills, strong communication and interpersonal skills, and the ability to effectively problem-solve, organize, and prioritize tasks under time pressure.
• A working knowledge of VICH, USDA, and/or EU GMP regulations for veterinary biologics is highly desirable.