Job Description

Job Title: Validation Scientist
Reports To: Department Leadership
Direct Reports: None

Position Overview:
The Validation Scientist is responsible for the execution and oversight of validation activities across equipment, processes, and cleaning procedures within a regulated manufacturing environment. This is a hands-on role focused on ensuring compliance with industry standards and internal quality requirements. The ideal candidate brings a strong scientific background, technical writing skills, and a collaborative, detail-oriented approach.

Key Responsibilities:

• Perform equipment qualification activities (IQ/OQ/PQ) for both new and existing manufacturing systems.

• Author and execute validation and qualification protocols and reports.

• Support cleaning and process validation initiatives in alignment with regulatory expectations.

• Analyze and interpret data to prepare clear, accurate validation documentation.

• Coordinate cross-functional validation activities across departments including Quality, Engineering, and Manufacturing.

• Investigate and resolve validation deviations; propose and support corrective actions as needed.

• Maintain current knowledge of validation requirements and evolving industry regulations.

• Contribute to the development and revision of SOPs, policies, and risk assessments.

• Represent the validation function during internal audits and regulatory inspections.

• Participate in continuous improvement initiatives related to validation programs.

Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmacy, or related field).

• Minimum of 3 years of validation experience in the pharmaceutical or life sciences industry.

• Strong working knowledge of cGMP guidelines and regulatory expectations.

• Familiarity with a variety of pharmaceutical manufacturing equipment.

• Proficient in Microsoft Office and related technical tools.

• Exceptional attention to detail with strong organizational and technical writing skills.

• Comfortable working in a hands-on, on-site environment.

Preferred Attributes:

• Strong collaboration and interpersonal communication skills.

• Ability to manage multiple priorities and deliver high-quality work under deadlines.

• Demonstrated ability to drive change and lead without direct authority.

• Previous exposure to operations, technical services, quality assurance, quality control, or regulatory affairs.

• Experience preparing and presenting validation documentation during audits.

• Familiarity with industry-standard validation practices including risk assessments and impact assessments.

• Commitment to safety and compliance in all activities.
  
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