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 require
• ments (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.

*Employment with Kinovate Life Sciences, Inc. (KLS) is at-will. This means your employment is for an indefinite period and it is subject to termination by you or KLS, with or without cause, with or without notice, and at any time. Nothing in the policy or any other policy of KLS shall be interpreted to in conflict with or to eliminate or modify in any way, the at-will employment status of KLS employees.

*KLS prohibits discrimination and harassment based on the following characteristics: race, color, caste, religion, religious creed (including religious dress and grooming practices), national origin, ancestry, citizenship, physical or mental disability, medical condition (including cancer and genetic conditions), genetic information, marital status, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender, gender identity, gender expression, age (40 years and over), sexual orientation, veteran or military status, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, and any other characteristic protected by state or federal antidiscrimination law covering employment. These categories are defined according to Government Code section 12920. In addition, KLS prohibits retaliation against a person who engages in activities protected under this policy. Reporting, or assisting in reporting, suspected violations of this policy and cooperating in investigations or proceedings.