Process Validation Specialist (Solid Dosage Manufacturing)

Process Validation Specialist (Solid Dosage Manufacturing)

Summary:
We are seeking a highly motivated and detail-oriented Process Validation Specialist to join our team at a solid dosage pharmaceutical manufacturing facility. The successful candidate will lead and support process validation efforts to ensure robust, reproducible, and compliant manufacturing processes. Experience in cleaning validation is a strong plus. This role plays a critical part in maintaining product quality and meeting regulatory expectations.

Responsibilities:

Process Validation:

* Lead the planning, execution, and documentation of process performance qualification (PPQ) studies for solid dosage manufacturing processes (e.g., blending, granulation, compression, coating, encapsulation).
* Perform process risk assessments and identify critical process parameters (CPPs) and critical quality attributes (CQAs).
* Ensure validation activities are aligned with regulatory guidelines (FDA, EMA, ICH Q8/Q9/Q10).
* Analyze process data to evaluate consistency, capability, and areas for improvement.
* Collaborate with Manufacturing, Quality, and Engineering teams to implement and maintain validated processes.

Cleaning Validation (Plus):

* Support cleaning validation activities as needed, including protocol development, execution, and data analysis.
* Assist in ensuring cleaning processes are effective, compliant, and aligned with product changeover requirements.

Documentation and Compliance:

* Author and review validation documentation such as Validation Master Plans (VMP), PPQ protocols, risk assessments, and validation summary reports.
* Ensure all validation deliverables meet internal quality standards and regulatory requirements.
* Participate in investigations and continuous improvement initiatives related to process performance.

Qualifications:

* Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related scientific discipline.
* Experience in process validation within a pharmaceutical manufacturing environment, preferably solid dosage.
* Strong understanding of PPQ study design, execution, and analysis.
* Familiarity with cleaning validation is a plus.
* Proficiency in technical writing and data interpretation.
* Working knowledge of cGMP, FDA, and ICH guidelines related to validation.

Job Types: Full-time, Contract

Schedule:

* 8 hour shift

Experience:

* cleaning validation: 3 years (Required)
* Validation in solid dosage: 3 years (Required)

Work Location: In person