Senior Principal Validation Engineer

Lake Pharma-posted 3 months ago
Senior
Albuquerque, NM
101-250 employees
Chemical Manufacturing
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Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. The Senior Principal Validation Engineer oversees Validation Contractors for the Albuquerque expansion and other key site projects. The majority of this role involves supervising relevant contractors at the Albuquerque site, including reviewing project proposals, interviewing, completing bid analysis, and selecting contractors. Responsibilities include managing projects and daily activities, overseeing validation activities, reviewing change controls, maintaining validated equipment, and updating validation documents such as the Validation Master Plan(s). Additional duties involve coordinating with departments to ensure timely completion of risk assessments, IQ, OQ, and PQ activities for new components, equipment, systems, and utilities, as well as developing and executing validation protocols for processes, equipment, utilities, and test systems. The role also supports new product introductions, equipment re-qualification schedules, and ensuring plant readiness post-shutdowns. The Senior Principal Validation Engineer will work with engineering, contractors, and facilities personnel to ensure proper system installation and operation, providing technical support for validated systems.

  • Develop and execute required protocols and complete reports for equipment, process utility, test, and revalidations as assigned.
  • Develop and write Standard Operating Procedures for new processes and equipment.
  • Support department projects by assisting engineers, calibrations, and validations on ongoing projects.
  • Support internal and external audits by providing and/or presenting data appropriate to the investigation as required.
  • Keep Department Management and personnel aware of Validation related issues that may have a regulatory compliance or financial impact.
  • Responsible for providing leadership to the contractors supporting the Validation program.
  • Ensure change controls, records, and procedures follow current Good Manufacturing Practices (cGMP) as well as Good Documentation Practices (GDPs).
  • Review and write validation protocols, final reports, and summaries of work for release of equipment tested.
  • Serve as validation liaison between the site and customers or regulatory agencies during facility audits.
  • Provide leadership and guidance to validation staff and contractors in the performance of their duties.
  • Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
  • Review and approve qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols and final report.
  • Review and approve validation protocols for computer related systems (as needed), environmental monitoring (if applicable), process validations and cleaning validations.
  • Coordinate and prioritize validation activities for the facility, in particular for key projects, according project timelines to ensure timeliness and with minimal disruption of production schedules, as applicable.
  • Write, update, approved, and maintain pertinent Validation Master Plans for the facility.
  • Ensure goals and objectives are met by contractors supporting Validation of existing projects.
  • Participate in the review of changes made under the Change Control System from a validation perspective.
  • Provide validation oversight to facility, utility and equipment upgrades.
  • Provide validation input to technology transfers.
  • Author, review, or approve impact assessments prepared by the Validation Department for change controls.
  • Read/interpret SOPs to ensure compliance.
  • Maintain up to date trainings.
  • Other duties as assigned.
  • Bachelor's degree in Science, Engineering, or relevant field.
  • Fifteen (15) years relevant experience in pharmaceutical validation (aseptic/sterile product facility).
  • Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.
  • Experience with FDA and EU regulations for pharmaceuticals and validation requirements.
  • Provides guidance and mentorship to team members.
  • Fosters a collaborative and positive work environment.
  • Champions change.
  • Promotes a safe and healthy work environment by actively identifying and addressing potential hazards.
  • Demonstrates strong attention to detail.
  • Excellent communication skills, both verbal and written.
  • Strong technical writing skills are required to author validation documentation.
  • Ability to work semi-independently; demonstrate ability to interact well with other technical departments.
  • Excellent presentation and influencing skills and the ability to interact and gain the support of senior management.
  • Excellent leadership and collaboration skills in a cross-functional and fast paced environment.
  • Ability to organize time to successfully manage multiple projects and priorities.
  • Ability to read, understand, interpret and implement technical writing and instructions.
  • Effective interpersonal relation skills, while maintaining the adaptability to achieve company goals.
  • Generous benefit options (eligible first day of employment).
  • Paid training, vacation and holidays (vacation accrual begins on first day of employment).
  • Career advancement opportunities.
  • Education reimbursement.
  • 401K program with matching contributions.
  • Learning platform.
  • And more!
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