Curia · 2 weeks ago
Validation Analyst II
Albuquerque, NM
Full-time
Onsite
Mid Level
3+ years expCuria is a global contract development and manufacturing organization with over 30 years of experience in providing life-saving treatments. The Validation Analyst II is responsible for executing and supporting validation activities for equipment, processes, utilities, systems, and components in alignment with cGMP regulations and internal procedures.
BiotechnologyHealth CareManufacturing
Responsibilities
Execute validation and qualification protocols for equipment, utilities, systems, and processes in accordance with cGMP, internal procedures, and regulatory requirements
Author and execute test scripts, accurately document validation data, and compile final reports to support qualification and release of validated items
Conduct small to medium validation projects under general supervision: Small projects: 1–2 test scripts, a single system or piece of equipment, one end customer, duration less than 1 month. Medium projects: 2–5 test scripts, multiple systems or pieces of equipment, multiple end customers, duration between 1–3 months
Review and verify validation documentation to ensure information is complete, accurate, and compliant with regulatory expectations
Coordinate with cross-functional teams (e.g., Quality, Manufacturing, Engineering) to ensure validation efforts align with production and quality timelines
Participate in change controls, investigations, and deviations as they relate to validation activities
Understand and implement site safety procedures and current Good Manufacturing Practices (cGMP)
Support departmental initiatives and continuous improvement efforts, including Operational Excellence projects
Stay current with industry regulations and best practices by reviewing pharmaceutical and regulatory publications
Notify management and team members of changes that may impact internal SOPs or validation requirements
Train and mentor junior validation staff, including Validation Technicians and Senior Technicians, on core validation tasks and documentation practices
Compile data into well-defined reporting formats and conduct basic comparative data analyses to support validation conclusions
Read/interpret SOPs to ensure compliance
Maintain up to date trainings
Other duties as assigned
Qualification
Required
Bachelor's degree in Computer Engineering, Physical Sciences, or relevant field of study
Minimum of three (3) years validation or related work experience
Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance
Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations
Strong written and verbal communication skills, along with effective presentation skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages
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 and deal with several abstract and concrete variables
Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions
Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
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
Demonstrates working knowledge of internal standards for written communication as they apply to controlled document changes/revisions
Verbally expresses ideas, facts, and proposals that are clear, logical, concise, and in accepted grammatical style
Independently prepares written communications in accepted grammatical style, which need little or no editorial corrections, and submit for review by supervision or a designee before being issued
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
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