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Senior Principal Validation Engineer

3 months ago

Albuquerque, United States curiate.co Full time

Senior Principal Validation Engineer in Albuquerque, NM

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

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.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients lives with the pharmaceuticals we develop and manufacture.

Essential Duties and 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.

+ 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

Education and/or Experience:

+ Bachelors 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

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, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

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, following established safety protocols, participating in safety training programs, and fostering 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

+ Ability to read, understand, interpret and implement technical writing and instructions

+ Effective interpersonal relation skills, while maintaining the adaptability to achieve company goals

+ Verbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical style

Other Qualifications:

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

May be required to obtain and maintain gowning certification

May be required to obtain and maintain media qualification

May be required to wear a respirator

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each positions physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia 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, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.