Senior Principal Validation Engineer

About the role

The Senior Principal Validation Engineer oversees Validation Contractors for the Albuquerque expansion and other key site projects. The role involves supervising relevant contractors, managing projects, overseeing validation activities, reviewing change controls, maintaining validated equipment, and updating validation documents.

Responsibilities

• 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.
• 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.
• Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
• 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.
• 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.
• 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.

Requirements

Education and/or Experience: Bachelor’s degree in Science, Engineering, or relevant field with a minimum of fifteen (15) years validation experience in pharmaceutical validation or aseptic/sterile product facility OR Master’s degree in Science, Engineering, or relevant field with thirteen (13) years validation experience in pharmaceutical validation or 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.

Qualifications

• 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.
• Supervisory Responsibilities: This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
• Language Skills: The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.
• Mathematical Skills: Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.
• Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Computer Skills: The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• Other Skills and Abilities: 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, follows established safety protocols, participates in safety training programs, and fosters a culture of awareness and responsibility among team members. 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, effective interpersonal relation skills, while maintaining the adaptability to achieve company goals.

Benefits

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!

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Full-time position with flexible scheduling to accommodate the needs of the role and the business.