Sr Validation Specialist

Responsibilities:

Ensures that qualification and validation of process systems comply with regulatory guidelines and standards.

Requires developing strategies and systems to improve process performance.

Ability to work in cross-functional teams with focus on deliverables, timelines, and meeting customer expectations and requirements.

Exercises judgment within defined procedures and practices to determine appropriate actions, uses rigorous logic and methods to solve difficult problems with effective solutions.

Implements corrective actions and coordinates activities in conjunction with the appropriate enabling groups, i.e. engineering, quality, maintenance, operations, etc.

Acts as project manager on validation projects. Partners with engineering to deliver projects that meet scope, schedule, and budget while fulfilling the operational needs of the project.

Provide guidance and lead the management of validation lifecycle for all equipment, facilities and utilities, including IQ/OQ/PQ, requalification/revalidation.

Own, manage, and monitor functional area/manufacturing projects and tasks and drive cross-functional projects to completion (such as capital projects)

Responsible for facility, utility and equipment qualification programs.

Responsible for cleaning validation program.

Support process validation PPQ protocol generation, execution and final reports

Collaborate with stakeholders and cross-functional teams to ensure alignment and coordination of validation activities with overall business objectives with clear communication and action.

Oversight of external validation resources on projects, including work prioritization and execution.

SME for validation projects in Internal and Regulatory inspections.

Requirements:

Minimum of 4-6 years of experience in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry.

Must have experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry.

Knowledgeable with the following: ultrafiltration and other filtration systems, cGMP facility design (cleanrooms, ISO classes, HVAC), utility systems common to the biopharmaceutical industry (e.g., WFI, RO water, compressed gases), clean-in-place (CIP) & (COP) equipment and cleaning cycles, clean room design, TCUs and operating principles.

Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations.

Basic knowledge of programmable logic controllers (PLCs) and instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required.

Experience executing capital projects is preferred.