Validation Analyst II

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…