Validation Engineer

SHINE Technologies LLC-posted 3 months ago
$75,000 - $90,000/Yr
Full-time • Mid Level
Janesville, WI
251-500 employees
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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. 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.

  • 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 being 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 are adhering to specified timelines.
  • Provide status and progress reports for validation/qualification activities or projects for the Management Review Meetings.
  • Review FDA and EMA regulations to ensure the validation activities meet defined requirements.
  • Validation Documentation Management:
  • Assist in the development and preparation of 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.
  • Perform periodic reviews of system(s) validation and reporting for the Annual Quality Product Review. Ensure appropriate plans are determined 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 (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis).
  • 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.
  • BS in scientific discipline or equivalent other work experience
  • Previous experience of 3-5 years in validation activities associated with 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.
  • 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.
  • Previous experience of 3-5 years in validation activities associated with pharmaceutical or medical device company is preferred
  • Pay Transparency Policy
  • Employee Rights Under the NLRA
  • Equal Opportunity Employment
  • E-Verify
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