Senior Executive/Assistant Manager, Process Validation & Cleaning Validation

Biocon Sdn Bhd; Gelang Patah; On-site; MYR 60,000 - 85,000; Full time

Job summary

Biocon Sdn Bhd seeks a Senior Executive/Assistant Manager to support Process Validation and Cleaning Validation activities across pharmaceutical manufacturing operations. The role encompasses validation lifecycle management, protocol execution, data analysis, and adherence to GMP and regulatory requirements.

The candidate will collaborate with Manufacturing, Quality Assurance, Engineering, and cross-functional teams to ensure compliant validation documentation, CAPA implementation, and readiness

Qualifications

• Bachelor's degree in Biotechnology, Pharmaceutical Science, Chemistry, Engineering, or related field.
• Experience in Process Validation, Cleaning Validation, or Validation within pharma/biotech/medical device or food industries.
• Good understanding of GMP, validation lifecycle, risk management, and regulatory requirements.

Responsibilities

• Prepare, review, and execute Process Validation and Cleaning Validation protocols and reports.
• Support qualification and validation activities for manufacturing processes.
• Analyze validation data and identify trends to ensure process consistency and product quality.
• Investigate validation deviations and implement corrective and preventive actions (CAPA).
• Collaborate with Manufacturing, Quality Assurance, Engineering, and cross-functional teams.
• Ensure validation documentation is maintained per GMP requirements.
• Support change control, risk assessments, and continuous improvement initiatives.
• Participate in regulatory inspections and audits related to validation activities.

Skills

Process Validation

Cleaning Validation

Validation lifecycle

Data analysis

GMP compliance

Regulatory requirements

CAPA

Change control

Risk assessment

Education

Bachelor's Degree

Job description

Senior Executive/Assistant Manager, Process Validation & Cleaning Validation

We are seeking a Senior Associate to support Process Validation and Cleaning Validation activities for pharmaceutical manufacturing operations. The successful candidate will be responsible for validation lifecycle management, execution of validation protocols, data analysis, and ensuring compliance with GMP and regulatory requirements.

Key Responsibilities

• Prepare, review, and execute Process Validation and Cleaning Validation protocols and reports.
• Support qualification and validation activities for manufacturing processes
• Analyze validation data and identify trends to ensure process consistency and product quality.
• Investigate validation deviations and implement appropriate corrective and preventive actions (CAPA).
• Collaborate with Manufacturing, Quality Assurance, Engineering, and other cross-functional teams to support validation activities.
• Ensure validation documentation is maintained in accordance with GMP requirements.
• Support change control, risk assessments, and continuous improvement initiatives.
• Participate in regulatory inspections and audits related to validation activities.

Requirements

• Bachelor's Degree in Biotechnology, Pharmaceutical Science, Chemistry, Engineering, or any related field.
• Experience in Process Validation, Cleaning Validation, or Validation within the pharmaceutical, biotechnology, or medical device industry or food industry
• Good understanding of GMP, validation lifecycle, risk management, and regulatory requirements.