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Validation Process Specialist

2 months ago

Indianapolis, Indiana, United States Randstad Life Sciences Full time
Job Description

Overview

The role involves executing and coordinating validation processes, including the qualification of isolators using vaporized hydrogen peroxide, airflow visualization studies, lifecycle modifications to primary packaging, and shipping validation activities. The position contributes to the Ongoing Process Verification program and change management activities to ensure compliance with cGMP requirements, maintaining quality and timeliness in alignment with corporate and global regulatory standards.

Key Responsibilities

Validation:

• Assist in project validation planning by developing and updating master plans for processes, process simulation studies, airflow visualization studies, packaging processes, and ongoing verification for processes and cleaning validation (as applicable).

• Support process validation lifecycle activities by ensuring a controlled state is maintained through ongoing process verification (OPV). Identify appropriate variables for continuous monitoring as part of quality risk management activities.

• Draft and review protocols and reports related to process, packaging, or process validation, as well as ongoing process and associated reports.

• Engage in hands-on execution of validation activities on the shop floor.

• Review Master Batch Records and associated change controls, confirming the need for revalidation based on technical changes.

• Keep all activities and projects under personal responsibility in an inspection-ready state.

• Provide technical expertise and facilitate pre-validation risk assessments using risk management tools. Collaborate cross-functionally to ensure that process risks are analyzed, controlled, and documented appropriately.

• Ensure that all site validation activities are conducted in accordance with current company requirements and cGMP, managing deviations associated with process validation and recommending resolutions to prevent recurrence.

Launch & Transfer:

• Collaborate closely with the development organization (or sending site) for technical transfers and new product launches to ensure effective knowledge transfer, appropriate control strategies, and risk analysis and management, ensuring that commercial processes are validation-ready.

• Participate in pre-validation activities and risk assessments to facilitate successful commercial process validation.

Performance Indicators

• Achieve established validation milestones according to approved validation plans in line with overall project timelines.

• Execute validation according to plan, serving as a measure of validation readiness activities.

• Audit and inspection outcomes as indicators of validation compliance with global regulatory expectations.

• Implement launches on target without preventable validation-related issues.

• Ensure validation protocols are executed and reports delivered on schedule.

• Maintain validation approaches that meet quality management requirements, health authority, and industry standards.

• Schedule validation, annual monitoring, and revalidation activities in collaboration with stakeholders to minimize disruption to site activities.

Education & Qualifications

Education (minimum/desirable):

• Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, or Pharmaceutical Technology.
Languages: Fluent in English and proficient in the local language.

Relevant Experience:

• 4-5 years of experience in manufacturing, manufacturing science and technology, technical development, or quality.

• Comprehensive understanding of manufacturing processes and related equipment.

• Strong knowledge of quality systems and regulatory requirements across various health authorities.

• Experience in executing process validation.

• Expertise in reviewing and drafting technical reports.

• Proven project management experience in a cross-functional environment (e.g., multi-site, technical development, other functions).

• Fundamental understanding of standard pharmaceutical analytical testing.

• Ability to work autonomously.