Validation Engineer
3 weeks ago
Job Description
Job Description
The Validation Engineer is responsible for design, planning, writing, and execution of protocols and studies at Kinovate Life Sciences. The perfect candidate is responsible for managing, coordinating, facilitating, and implementing process, equipment, software, product validations, and qualifications requirements. The role will focus on implementation of new facilities, equipment, process improvement and ensuring compliance with KLS policies and procedures and conformance with customer requirements.
Specific Duties and Responsibilities:
Participate in the development, implementation, management and integration of a Qualification and Validation plans for all KLS production activities and products.
Design testing criteria and procedures including acceptance criteria for validation purposes.
Be able to perform all aspects of the validation program URS, DQ, IQ,OQ,PQ
Identify Risks, Process Gaps and Quality Issues and work to mitigate them through validation activities.
These will encompass new
facility/equipment/process,
process and equipment changes, and periodic
requalification/revalidation
Provide Validation, Engineering and Process Expertise to developing new processes.
Conducts testing including setup, execution and data collection.
Constructs and executes controlled experiments.
Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
Requirements:
Bachelor’s degree in science or equivalent work experience.
Experience (3-4 years) working in a GMP or ISO regulated environment.
Experience with Oligo synthesis manufacturing
Ability to interpret regulatory standards including USP and ISO develop risk-based decision making that ensures compliance with applicable governance.
Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210)
Strong understanding of quality risk management principles, including best practice in risk-based C&Q approach
Hands on validation experience in developing validation documentation and field execution.
Experience (1-2 years) in a Quality related role in a controlled work environment.
Experience in executing studies and/or Validation protocols.
ASQ certification such as CQA or CQE is a plus.
Must have excellent skills in organization, negotiation, problem solving and time-management.
Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.
Ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs
Expert Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills are required
Understanding of basic statistics, acceptance sampling, and familiar with statistics software such as Minitab and JMP
Able to attend to detail and act decisively.
Ability to work under pressure, manage several tasks at once and meet tight deadlines.
Must have excellent interpersonal, written, oral presentation and verbal communication skills.
Company Description Kinovate Life Sciences, Inc. was established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) with a mission to provide the highest quality materials to niche life science markets worldwide. Since Its inception that time, Kinovate has grown to become the market leader in the market for solid supports in the oligonucleotide synthesis field. With a history of success based on outstanding materials, superior service and competitive costs, Kinovate has established itself as the reliable supplier of choice to oligonucleotide drug development companies, contract manufacturers, oligo houses and numerous other players in the field. Kinovate boasts unparalleled resources in the areas of R&D, manufacturing, analytical development, Quality Control, technical and a World Class customer support. Kinovate and has built a dedicated and hardworking team with a commitment to continuous improvement, that strives to provide the highest quality products at the best prices.
Company Description
Kinovate Life Sciences, Inc. was established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) with a mission to provide the highest quality materials to niche life science markets worldwide. Since Its inception that time, Kinovate has grown to become the market leader in the market for solid supports in the oligonucleotide synthesis field. With a history of success based on outstanding materials, superior service and competitive costs, Kinovate has established itself as the reliable supplier of choice to oligonucleotide drug development companies, contract manufacturers, oligo houses and numerous other players in the field. Kinovate boasts unparalleled resources in the areas of R&D, manufacturing, analytical development, Quality Control, technical and a World Class customer support.
Kinovate and has built a dedicated and hardworking team with a commitment to continuous improvement, that strives to provide the highest quality products at the best prices.
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