Validation Engineers - Onsite - Nebraska
(Pharmaceutical/Biotech)-Competitive Salary, Work/Life Balance!
We offer W-2, 1099, Agency Opportunities
Previous Pharmaceutical/Biotech/Medical Device Sr.PM experience is mandatory
Are you looking to be a part of a close-knit work community? Do you have experience in the Life Science industry? Will you represent Compli, LLC as a Project Engineer with CQV experience for our client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you!
Compli LLC is a full-service regulatory compliance consulting services company with a life sciences division specializing in pharma, biotech, API, Medical devices, and laboratory facilities. We are seeking a Junior Validation Engineer.
- Preparation/Execution/Review of Validation Plans (VP), System Impact Assessments (SIA), Requirements Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), and Validation Summary Report (VSR) for equipment, analytical/laboratory equipment, critical systems and utilities, Process Performance Qualification (PPQ) for the product manufacturing process and Release Authorization to release validated items into use.
- Evaluate changes to any validated systems, equipment, process, or procedure in terms of their effect on the state of validation through the change control program and in Compliance with the Quality System, using tools like Risk Assessment, FMEA, and others.
- Develop/Review SOPs that meet all applicable regulatory requirements.
- Works with appropriate parties to provide corrective and preventive actions based on sound engineering analysis.
- Develop/review computer validation strategies including the development and review of computer validation documents such as user requirements specifications, validation plans, function, and design specifications, testing protocols, risk assessments, and validation summary reports, under FDA 21CFR11.
- Reviews and ensures all process, material, and procedural changes are appropriate and in compliance with regulatory requirements, ISO, and quality policies of the company.
- Reviews and ensures all qualification and validation documents are compliant with all applicable regulatory requirements and quality policies of the company.
- Bachelor's degree in an engineering field; Life Science and Pharmaceutical industry experience.
Validation Engineer minimum of 3-5 years' experience.
- Ability to converse about biologics and pharmaceutical manufacturing topics
- Ability to work independently or in collaboration with others. Proficient in current Good Manufacturing Practices and other applicable FDA, USDA, and EU regulations
- Excellent client-facing relationship-building skills
- Excellent written and verbal communication skills
- Solid organizational skills including attention to detail and multitasking skills
- Proficient in MS Excel, MS Word, MS Project, MS PowerPoint, MS Access, and AutoCAD Lite.
Validation Engineer needs experience in Temp Mapping. Preference would be using Kaye AVS, Kaye Validator 2000 equipment, Ellab, Vaisla preferred.
- Require GMP Water systems, Utility Systems / gases, Utility systems / waste / Biowaste
- Experienced in Requalification of Biological process equipment. (Controlled Temperature Units) CTUs, Autoclaves, Washers, Steam in Place - SIP of vessels.
- Must be able to work independently
was founded in 2001 to provide commissioning, validation, and regulatory support services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team.Perks of the Job:
- Competitive Pay commensurate with experience
- Work / Life Balance
- Working with a small, close-knit team where you are valued as an individual
- A learning environment and continuous advancement opportunities
Feel overqualified? Feel underqualified? Apply anyway if this sounds like the fit you are looking for! We have flexibility in how we hire the role.
To learn more and APPLY NOW: http://www.ucompli.com/careers
Agencies, Compli welcomes your qualified candidates. Please email:
email@example.com to establish a relationship with our firm. We are an equal opportunity employer M/F/D/V Job Keywords:
Unites States, Nebraska, North Platte, NE, Lincoln, NE, Omaha, NE, Kansas City, KS, Kansas City, MO., Missouri, Kansas, Overland Park, KS, Olathe, KS, commission, qualification, validation, CQV, Pharmaceutical, GMP Pharma, Biotech Industry.
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