About the job

Company Description

Augmented is a Managed Services and IT Consulting provider operating from three delivery hubs in Canada, the US, and the UK with a focus on regulated industries including the Pharmaceutical Industry.

Role Description

We are seeking a Senior Validation Specialist to lead validation activities at our client’s pharmaceutical manufacturing facility in Indianapolis, IN. The role is responsible for ensuring that facilities, utilities, equipment, computerized systems, and manufacturing processes remain in a validated, inspection‑ready state in accordance with FDA, EU GMP, and internal quality standards. The Senior Validation Specialist will act as a subject matter expert (SME), partnering closely with Engineering, Quality, Manufacturing, and IT to plan, execute, and continuously improve the site’s validation program.

Key Responsibilities:

Lead the development, execution, and maintenance of validation lifecycle documentation, including Validation Master Plan (VMP), risk assessments, validation plans, protocols (IQ/OQ/PQ), and summary reports for facilities, utilities, equipment, and processes.

Plan and execute process validation, cleaning validation, and revalidation activities for drug product manufacturing and packaging operations, ensuring compliance with current regulatory guidance (e.g., FDA Process Validation, EU GMP Annex 1/11, GAMP 5).

Coordinate and perform qualification activities for new and modified equipment and systems, including drafting and executing URS, DQ, IQ, OQ, and PQ protocols for production and QC laboratory equipment, utilities, and computerized systems (e.g., LIMS, MES).

Serve as CSV SME (Computerized Systems Validation) for relevant systems, producing and reviewing validation plans, test scripts, requirements traceability, and data integrity controls in line with 21 CFR Part 11 and industry expectations.

Review and approve validation‑related documents, including SOPs, change controls, deviations, CAPAs, qualification reports, and calibration records, ensuring alignment with GMP and site procedures.

Analyze validation and qualification data, perform trending and statistical evaluations as needed, and write clear, audit‑ready reports that support validation conclusions and ongoing process capability.

Act as validation SME during internal, client, and regulatory audits; prepare and defend validation strategies, documentation, and results in collaboration with QA and site leadership.

Lead or support investigations and root cause analysis related to deviations, non‑conformances, and validation failures; propose and implement CAPAs to prevent recurrence.

Provide training and mentoring to junior validation engineers/specialists and cross‑functional staff on validation concepts, protocols, and GMP expectations.

Maintain the validated state of systems and processes through periodic reviews, impact assessments for changes, and timely execution of revalidation activities.

Stay current with evolving regulations and industry best practices in pharmaceutical validation and CSV; contribute to continuous improvement of the site validation program and standards.

Required Qualifications

Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related STEM discipline.

Minimum 5–7 years of validation experience in the pharmaceutical or biopharmaceutical industry, with significant exposure to manufacturing and packaging environments.

Demonstrated experience executing and/or leading equipment, utility, and process qualifications (IQ/OQ/PQ), including blending, granulation, compression/encapsulation, coating, liquid mixing/filling, and packaging operations, or comparable unit operations.

Strong knowledge of cGMP regulations and relevant guidance (e.g., FDA Process Validation, EU GMP Annex 1/11, GAMP 5, 21 CFR Part 11) and their practical application to validation programs.

Hands‑on experience preparing and reviewing core validation documentation, including VMPs, URS, risk assessments, validation plans, protocols, reports, and change impact assessments.

Proven ability to manage multiple validation projects simultaneously, prioritize activities, and meet deadlines in a fast‑paced manufacturing environment.

Excellent written and verbal communication skills, with the ability to explain complex validation concepts to technical and non‑technical stakeholders and to produce clear, audit‑ready documentation.

Strong interpersonal skills and demonstrated ability to collaborate effectively with QA, Engineering, Operations, IT, and external partners/clients.

Preferred Qualifications

Master’s degree in Engineering, Pharmaceutical Sciences, or related field.

Experience in sterile or injectable pharmaceuticals, or in highly regulated dosage forms requiring rigorous process and cleaning validation.

Significant CSV experience across manufacturing, laboratory, and quality systems (e.g., LIMS, MES, SCADA/DCS), including data integrity and Part 11 compliance.

Prior client‑facing or CDMO experience, supporting tech transfers, product launches, and external audits.

Proficiency with statistical tools/software (e.g., JMP or similar) for validation data analysis and process capability assessment.

Core Competencies:

Technical expertise in pharmaceutical validation and GMP compliance.
Strong problem‑solving, risk‑based thinking, and root cause analysis skills.
High attention to detail and documentation quality.
Ownership mindset with ability to drive projects independently while working cross‑functionally.
Continuous improvement orientation, staying current with regulatory and industry developments