Validation Lead bei SHINE Technologies LLC

Description

SHINE Technologies is seeking a Validation Lead who will be responsible for overseeing and executing validation activities to ensure systems, processes and products meet specified requirements and regulatory standards. This involves developing, implementing and managing validation strategies, leading validation initiatives and ensuring compliance to quality standards and regulations. The Validation Lead will create and review validation documentation, participate in audits and mentor team members on validation processes and requirements. The Validation Lead will support Therapeutics validation activities in the commercial manufacturing facility.

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.

Duties and Responsibilities:

Specific duties and responsibilities include, but are not limited to:

• Developing and Implementing Validation Strategies:
• Create and maintain validation plans, protocols, and reports, ensuring they align with regulatory requirements and project goals.
• Manage Master Validation Plan, through the review and implementation of all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
• Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
• Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
• Responsible for overseeing Qualification/Validation initiatives/projects and personnel ensuring adherence to timelines and deliverables.
• Provide status and progress reports for validation/qualification activities or projects for the Management Review Meetings.
• Validation Documentation Management:
• Drafting URS documents for major equipment purchases and support the onboarding of equipment into the cGMP system.
• Develop and prepare protocols for process qualification, cleaning validation, equipment commissioning and qualification (including but not limited to 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, obtain necessary approvals. 
• Prepare documentation and provide support for regulatory/compliance inspections. 
• Support internal and external audits, regulatory inspections, and remediation efforts related to software validation and compliance. 
• Review and approve periodic reviews of system(s) validation. Ensure appropriate plans are determined for gaps identified during periodic reviews. 
• Mentor and Train Team Members on Validation Processes and Requirements: 
• Coordinating activities and ensuring efficient execution of validation tasks.
• Support training activities related to qualification and validation activities through assignments in ACE (electronic Quality Management System) and on the job training (OJT). 
• Risk Management:
• Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis). 
• Responsible for keeping the qualification/validation of the facility, equipment and processes current.
• Reviews proposed changes for impact to system qualification and validation. Identifies and completes requalification activities to support change completion. 
• Collaboration:
• Working closely with cross-functional teams (e.g., R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables.
• Collaborates with cross-functional teams to meet project objectives, timelines, including scheduling, qualification testing, and deviation resolution. 
• Continuous Improvement:
• Identifying opportunities for improvement in validation processes and procedures and implementing corrective actions. 

Requirements

• BS in scientific discipline or equivalent other work experience 
• Previous experience of 3-5 years in pharmaceutical or medical device company is preferred 
• Experience in cGMP environments
• Strong understanding of validation principles, methodologies, and regulatory requirements.
• Experience in 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 and Physical Effort: 

• Requires frequent leaning, bending, stooping, crouching, grasping, and reaching above the shoulders and below the knees.
• Moderate physical activity. Requires handling of average-weight objects up to 40 pounds or standing and/or walking for more than four (4) hours per day. 
• Fine motor coordination and strong depth perception is beneficial.
• Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises. 
• Work environment involves some exposure to hazards or physical risks, which require following basic safety precautions. 

Employees must be able to perform the essential functions of the position satisfactorily. If requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

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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