Validation Engineer

Karwell Technologies

Waltham, MA

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JOB DETAILS

SKILLS

Asepsis, Autoclave, Biotech and Pharmaceutical, Budgeting, CIP (Clean-in-Place), Calibration, Code of Federal Regulations, Cross-Functional, Detail Oriented, Drug Manufacturing, GMP (Good Manufacturing Practices), Identify Issues, Maintain Compliance, Manufacturing, Operations Management, Performance Analysis, Performance Metrics, Problem Solving Skills, Process Validation, Quality Engineering, Regulatory Compliance, Risk, Standard Operating Procedures (SOP), Sterilization, System Validation, Team Player, Validation Documentation, Validation Plan

LOCATION

Waltham, MA

POSTED

30+ days ago

Job Description:

We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment.
This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV).

Roles & Responsibilities:

Perform validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment
Ensure compliance with GMP and 21 CFR Part 11 standards
Develop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization procedures
Conduct equipment qualification activities (IQ/OQ/PQ) and ongoing performance monitoring
Perform instrument calibration for equipment such as dual display light meters, open air shakers, and various scales
Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts washers, and autoclaves
Execute validation projects, ensuring timelines, budgets, and KPIs are met
Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve validation discrepancies
Apply a risk-based approach to validation to ensure compliance and operational efficiency
Coordinate resources and activities for complex validation and CSV initiatives
Requirements:
Experience in validation, calibration, or CQV within a pharmaceutical or regulated environment.
Strong knowledge of GMP and 21 CFR Part 11 compliance.
Proven experience with Computerized System Validation (CSV).
Hands-on experience with IQ/OQ/PQ and validation lifecycle documentation.
Strong problem-solving, communication, and cross-functional collaboration skills.

Validation Engineer

Karwell Technologies

Waltham, MA

About the Company

Karwell Technologies

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