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1+ months

Lab Equipment Validation Engineer

Kelly Services
Schaumburg, IL 60173
**Laboratory Validation Engineer - Direct Hire**


Kelly Engineering Resources is searching for a Laboratory Validation Engineer on behalf of our client a pharma/medical device manufacturer. In this role, you will report to the Manager of Quality and Validation. Your main focus is to ensure that all laboratory equipment, systems, instruments, and methods/processes comply with the Quality Management Systems and remain in a constant validated state.


You will ensure that all laboratory equipment, systems, instruments, methods/processes:


+ Are running appropriately, maintained and qualified according to specifications, procedures, validation requirements, equipment control requirements and operate within regulatory requirements.

+ Remain in the validated state, revalidated as needed, upgraded or maintained as required and are periodically monitored to ensure the state of operation and control meets regulatory expectations and current industry standard from a validation, qualification, Data Integrity and Quality System requirements.


You will utilize supplier/vendor/service provider resources and third-party experts as needed while maintaining compliance to Supplier Quality requirements, monitoring and oversight.


Our client offers the following benefits:


+ Comprehensive insurance coverage that includes Medical (BC/BS of IL PPO or Blue Edge HSA), Vision, Life and disability insurance plans along with enhanced Dental benefits.

+ FSA

+ Pet Insurance

+ Wellness program including an onsite fitness center.

+ 401K, 50% match up to 2.5% of salary

+ 13 Paid Holidays

+ 2 Weeks' vacation

+ Competitive annual bonus and sales incentive programs


**Essential Responsibilities**


+ Establish and maintain current/compliant validation standards (procedures, forms, templates) and validation master plans that encompass the totality of the laboratory operations, systems, processes and scope of work.

+ Understand the applicable process technologies, USP methods, SAI products, Quality System and compliance requirements to effectively engage in technical discussions, take initiative to maintain, monitor and improve the laboratory controls and the validation program.

+ Understand and identify key validation/revalidation needs, critical process parameters and critical quality attributes for laboratory equipment, instruments, methods, systems, and processes.

+ Develop testing protocols and controls (calibration, maintenance, cleaning, inspection) for laboratory systems, instruments, methods, equipment validations, including IQ, OQ, PQ, test method validation, cleaning systems validation, and computer systems validation.

+ Supports the product design verification and validation, and site validation program overall.

+ Serve as protocol Study Director / Coordinator / Lead as required.

+ Collect and statistically analyze validation data, process monitoring results, comparability of equipment/instrument/method/process performance, method variability and human factors impact.

+ Compose validation summary reports, interim/progress reports and validation schedules.

+ Review change controls and proposed changes/upgrades/modifications to determine the appropriate level of validation/revalidation required. Present plans/proposals/progress to various review boards.

+ Manage the laboratory Master Validation Plan.

+ Maintain validation records.

+ Ensure compliance with safety, quality, and regulatory standards.

+ Support preparation, execution of internal and external audits and inspections as well as compliance remediation initiatives.

+ Other duties as assigned by management.


**Qualifications of the Successful Laboratory Validation Engineer**


+ Bachelors Degree in Science or Engineering, required

+ CQE or equivalent certification a plus


+ 5+ years of validation/qualification experience in the medical device or pharmaceutical industries, required.

+ Creating and executing validation/qualification protocols (IQ, OQ, PQ), installation, operational, performance validations

+ Defining critical process parameters, critical quality attributes, summary reports, protocol deviations and out-of-specification investigations.

+ Working knowledge of FDA drug and medical device regulations (ISO 13485), current validation industry standards, validation and laboratory guidance documents, risk management requirements, Supplier Quality requirements, Laboratory Controls and Data Integrity requirements.

+ 5+ years experience with laboratory equipment, instruments, systems and methods including: incubators, coolers, refrigerators, HPLC, GC, purified water systems, glass washers, laboratory software, hoods, biosafety cabinets, USP methods, tools/utensils, tensile strength / retention tester, etc.

+ Experience in change controls, change management, document management and CAPA.

+ Understanding of SPC, Design of Experiments, feasibility studies, comparative analysis and various other statistical and data analysis techniques.


Skills


+ Coordinate with end users and process owners to lead development of appropriate protocols and reports, validation master plans and laboratory controls.

+ Proficient in Microsoft Word, Excel, Project management software Adobe Acrobat.

+ Strong verbal communication and technical writing skills.

+ Strong analytical skills, time management and can plan ahead to meet schedules, due dates and requirements that keep the lab in operation and in compliance.

+ Knowledge of statistical software analysis (e.g. Minitab)

+ Understanding of laboratory processes and safety regulations

+ Attention to detail and strong understanding/ownership of the importance of compliance and Data Integrity.

+ Ability to work independently, take initiative and identify solutions and improvements

+ Ability to apply risk-based methodologies and working risk management principles in establishing and maintaining a compliant laboratory validation program.


**\#TJP2021_SPEC**


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-04-25 Expires: 2022-06-11

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Lab Equipment Validation Engineer

Kelly Services
Schaumburg, IL 60173

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