Validation Analyst II

Job description

Validation Analyst II, Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

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.

We proudly offer


+ 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!


Summary:

The Validations Department is responsible for formulating, reviewing, and approving all validation protocols related to manufacturing or support operations.

The Validation Analyst II is responsible for executing and supporting validation activities for equipment, processes, utilities, systems, and components in alignment with cGMP regulations, internal procedures, and applicable regulatory expectations.

This intermediate-level role involves authoring, reviewing, and executing validation protocols; analyzing test results; and compiling final reports to support qualification and ongoing validation efforts.

The Validation Analyst II collaborates with cross-functional teams to ensure validation work is efficiently integrated into production and quality timelines.

This role may also support investigations related to validation deviations, participate in risk assessments, and contribute to the development and continuous improvement of validation practices.

Essential Duties and 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


Education and Experience:


+ 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


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

+ 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.


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


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 position’s 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.





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Required Skill Profession

Other General