SHINE Technologies
Overview
SHINE Technologies is seeking a
Validation Engineer
to be responsible for the execution of validation activities to ensure systems, processes and products meet specified requirements and regulatory standards. This involves assisting in the development and execution of validation protocols while ensuring compliance to quality standards and regulations. The Validation Engineer will assist in creation, execution, and review of validation documentation. The Validation Engineer will support Therapeutics validation activities in the commercial manufacturing facility. Salary information: The base salary range for this position is $75,000 - $90,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location. Responsibilities
Developing and implementing validation strategies. Create and maintain validation protocols and reports, ensuring they align with regulatory requirements and project goals. Lead the development of risk assessments in relation to validation activities. Ensure validation activities are performed in accordance with SHINE validation policies, procedures, and the Master Validation Plan. Coordinate and help execute approved protocols for process validation, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification/revalidation of critical systems and utilities. Provide input and guidance on new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes. Ensure validation initiatives adhere to specified timelines. Provide status and progress reports for validation/qualification activities or projects for Management Review Meetings. Review FDA and EMA regulations to ensure validation activities meet defined requirements. Assist in the development and preparation of protocols for process qualification, cleaning validation, equipment commissioning and qualification (including FAT/SAT/IOQ and PQ) as well as CSV (Computer Software Validation) documentation to ensure data integrity requirements are met. Review and analyze analytical and physical data generated from executed validation/qualification activities. Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, and obtain necessary approvals. Prepare documentation and provide support for regulatory/compliance inspections. Perform periodic reviews of system validation and reporting for the Annual Quality Product Review, and determine plans for gaps identified during periodic reviews. Risk management: Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment (e.g., Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, FMEA). Review proposed changes for impact to system qualification and validation; identify and complete requalification activities to support change completion. Collaboration: Work closely with cross-functional teams (e.g., R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables; coordinate with teams to meet objectives and timelines, including scheduling, qualification testing, and deviation resolution. Continuous Improvement: Identify opportunities for improvement in validation processes and procedures and implement corrective actions. Qualifications
BS in a scientific discipline or equivalent experience. 3-5 years of experience in validation activities in pharmaceutical or medical device environments preferred. Experience in cGMP environments. Strong understanding of validation principles, methodologies, and regulatory requirements. Experience drafting and executing qualification documents (IQ, OQ, PQ). Ability to write procedures and protocols and review documentation. Ability to lead and motivate teams, manage projects, and communicate effectively. Ability to analyze data, identify risks, and develop effective solutions. Ability to identify and resolve issues related to validation and compliance. Excellent written and verbal communication skills for interacting with cross-functional teams and stakeholders. Working Conditions
Requires frequent bending, stooping, crouching, grasping, and reaching. Moderate physical activity; ability to handle objects up to 40 pounds; standing or walking for extended periods. Fine motor coordination and depth perception are beneficial. Exposure to typical manufacturing environment elements (temperatures, dust, fumes, odors, and noise). Work environment involves some exposure to hazards or safety risks with standard precautions. Employees must be able to perform the essential functions of the position; reasonable accommodations will be made when requested, absent undue hardship. Eligibility for employment may be conditioned on access to information subject to U.S. Export Controls and meeting Nuclear Regulatory Commission requirements for access to Safeguards Information, which may involve pre-employment screening. SHINE values diversity in all forms as part of innovation; SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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SHINE Technologies is seeking a
Validation Engineer
to be responsible for the execution of validation activities to ensure systems, processes and products meet specified requirements and regulatory standards. This involves assisting in the development and execution of validation protocols while ensuring compliance to quality standards and regulations. The Validation Engineer will assist in creation, execution, and review of validation documentation. The Validation Engineer will support Therapeutics validation activities in the commercial manufacturing facility. Salary information: The base salary range for this position is $75,000 - $90,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location. Responsibilities
Developing and implementing validation strategies. Create and maintain validation protocols and reports, ensuring they align with regulatory requirements and project goals. Lead the development of risk assessments in relation to validation activities. Ensure validation activities are performed in accordance with SHINE validation policies, procedures, and the Master Validation Plan. Coordinate and help execute approved protocols for process validation, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification/revalidation of critical systems and utilities. Provide input and guidance on new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes. Ensure validation initiatives adhere to specified timelines. Provide status and progress reports for validation/qualification activities or projects for Management Review Meetings. Review FDA and EMA regulations to ensure validation activities meet defined requirements. Assist in the development and preparation of protocols for process qualification, cleaning validation, equipment commissioning and qualification (including FAT/SAT/IOQ and PQ) as well as CSV (Computer Software Validation) documentation to ensure data integrity requirements are met. Review and analyze analytical and physical data generated from executed validation/qualification activities. Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, and obtain necessary approvals. Prepare documentation and provide support for regulatory/compliance inspections. Perform periodic reviews of system validation and reporting for the Annual Quality Product Review, and determine plans for gaps identified during periodic reviews. Risk management: Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment (e.g., Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, FMEA). Review proposed changes for impact to system qualification and validation; identify and complete requalification activities to support change completion. Collaboration: Work closely with cross-functional teams (e.g., R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables; coordinate with teams to meet objectives and timelines, including scheduling, qualification testing, and deviation resolution. Continuous Improvement: Identify opportunities for improvement in validation processes and procedures and implement corrective actions. Qualifications
BS in a scientific discipline or equivalent experience. 3-5 years of experience in validation activities in pharmaceutical or medical device environments preferred. Experience in cGMP environments. Strong understanding of validation principles, methodologies, and regulatory requirements. Experience drafting and executing qualification documents (IQ, OQ, PQ). Ability to write procedures and protocols and review documentation. Ability to lead and motivate teams, manage projects, and communicate effectively. Ability to analyze data, identify risks, and develop effective solutions. Ability to identify and resolve issues related to validation and compliance. Excellent written and verbal communication skills for interacting with cross-functional teams and stakeholders. Working Conditions
Requires frequent bending, stooping, crouching, grasping, and reaching. Moderate physical activity; ability to handle objects up to 40 pounds; standing or walking for extended periods. Fine motor coordination and depth perception are beneficial. Exposure to typical manufacturing environment elements (temperatures, dust, fumes, odors, and noise). Work environment involves some exposure to hazards or safety risks with standard precautions. Employees must be able to perform the essential functions of the position; reasonable accommodations will be made when requested, absent undue hardship. Eligibility for employment may be conditioned on access to information subject to U.S. Export Controls and meeting Nuclear Regulatory Commission requirements for access to Safeguards Information, which may involve pre-employment screening. SHINE values diversity in all forms as part of innovation; SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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