Curia · 1 day ago
Senior Principal Validation Engineer
Albuquerque, NM
Full-time
Onsite
Senior Level, Lead/Staff
13+ years expCuria is a global contract development and manufacturing organization dedicated to providing life-saving treatments. The Senior Principal Validation Engineer oversees validation contractors and manages validation activities to ensure compliance and operational readiness at the Albuquerque site.
BiotechnologyHealth CareManufacturing
Hiring Manager
Hang Nguyen
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
Qualification
Required
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
Ability to read and interpret various documents including safety instructions, standard operating procedures, technical procedures, and governmental regulations
Strong written and verbal communication skills
Effective presentation skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement
Strong grasp of algebraic and geometric principles
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
Strong technical foundation and proven capability in effectively utilizing diverse software tools
Adeptness in manufacturing and internet software
Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
Ability to provide guidance and mentorship to team members
Ability to foster a collaborative and positive work environment
Ability to champion change
Ability to promote a safe and healthy work environment
Strong attention to detail
Excellent communication skills, both verbal and written
Strong technical writing skills required to author validation documentation
Ability to work semi-independently
Excellent presentation and influencing skills
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
Ability to verbally express ideas and facts in a clear, logical, concise, and accepted grammatical style
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
Preferred
May be required to obtain and maintain media qualification
May be required to wear a respirator
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!
Company
Curia
Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.
1001-5000 employees
H1B Sponsorship
Curia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2025-03-07Debt Financing
2017-08-31Private Equity
Leadership Team
Steve Lavezoli
Vice President, Biologics Division
Recent News
2025-10-31
thecanadianpressnews.ca
2025-10-29
Curia Global, Inc.
2025-10-27
Company data provided by crunchbase