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CSV Engineer/QA Analyst
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Seeking 2 CSV Engineer/QA Analyst
Description:
Must be able to sit on site in Elwood, KS.
From the client:
Job Responsibilities
o 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.
o Ensure execution of capital projects consider USDA and EMA regulatory and quality requirements.
o Review relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, validation plans / protocols, etc.
o Escalate protocol departures of critical nature and ensure issues are addressed and remediated accordingly
o Provide technical consultation and interpretation local procedures, corporate standards and regulatory expectations.
o Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures. Exemplify "Safety First and Quality Always" mind-set.
Basic Requirements
o Bachelor's of Science degree in Engineering or related fields
o 3+ years supporting cGMP manufacturing?
Additional Skills Preferences
o Prior experience in C&Q, CQV and/or CSV
o Proficient with computer systems including Microsoft office and electronic document management systems (Veeva)
o Ability to organize and prioritize multiple tasks and to problem solve effectively
o Ability to work under time pressure and exert good judgement in special situations
o Strong communication and interpersonal skills
o Excellent technical writing skills.
o Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.
Skills:
Quality assurance, CSV, Validation, Regulatory Compliance
o Eligibility requirements apply to some benefits and may depend on your job classification and length of employment.
Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role
may include the following:
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Description:
Must be able to sit on site in Elwood, KS.
From the client:
Job Responsibilities
o 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.
o Ensure execution of capital projects consider USDA and EMA regulatory and quality requirements.
o Review relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, validation plans / protocols, etc.
o Escalate protocol departures of critical nature and ensure issues are addressed and remediated accordingly
o Provide technical consultation and interpretation local procedures, corporate standards and regulatory expectations.
o Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures. Exemplify "Safety First and Quality Always" mind-set.
Basic Requirements
o Bachelor's of Science degree in Engineering or related fields
o 3+ years supporting cGMP manufacturing?
Additional Skills Preferences
o Prior experience in C&Q, CQV and/or CSV
o Proficient with computer systems including Microsoft office and electronic document management systems (Veeva)
o Ability to organize and prioritize multiple tasks and to problem solve effectively
o Ability to work under time pressure and exert good judgement in special situations
o Strong communication and interpersonal skills
o Excellent technical writing skills.
o Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.
Skills:
Quality assurance, CSV, Validation, Regulatory Compliance
o Eligibility requirements apply to some benefits and may depend on your job classification and length of employment.
Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role
may include the following:
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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