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Associate Manager, Engineering - Validation - Job Opportunity at Lonza

Tuas, Singapore
Full-time
Senior
Posted: March 20, 2025
On-site
SGD 90,000 - 120,000 per year based on Singapore's biotech sector compensation trends and role seniority

Benefits

Exposure to global biotech projects and cutting-edge manufacturing technology
Career development and ownership opportunities
Professional training and mentorship programs
Participation in innovative healthcare solutions development

Key Responsibilities

Lead and ensure regulatory compliance of site validation lifecycle program
Manage and mentor validation team members for operational excellence
Direct validation activities according to SOPs and strategic plans
Coordinate with quality units and stakeholders on validation program execution
Oversee validation deviation investigations and corrective actions
Drive data integrity initiatives and process improvements

Requirements

Education

Bachelor Degree / Diploma

Experience

Previous validation management experience required

Required Skills

Biopharmaceutical industry knowledge Regulatory compliance expertise (FDA, EMEA, GAMP, ICHQ7) GMP facility validation experience Leadership and communication skills Quality decision-making abilities Analytical approach Project management capabilities Safety and quality focus
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on biologics manufacturing capabilities in APAC region with Singapore as a key hub Growing demand for validation expertise due to stricter regulatory requirements and complex manufacturing processes Shift towards automated validation systems and digital compliance tools Rising importance of data integrity in validation processes

Role Significance

Typically manages 5-8 validation specialists in a biologics manufacturing facility of this scale
Mid-to-senior management position with significant influence on facility compliance and operational excellence

Key Projects

Facility qualification and validation programs Process validation for new biological products Computer system validation implementations Regulatory compliance initiatives Validation master plan execution

Success Factors

Strong understanding of regulatory landscape and GMP requirements Ability to balance technical expertise with people management Strategic thinking in validation program development Effective stakeholder management across quality, operations, and client teams

Market Demand

High demand due to expansion of biologics manufacturing facilities in Singapore and limited pool of experienced validation managers

Important Skills

Critical Skills

Validation management expertise in GMP environment Regulatory compliance knowledge Leadership and team management Technical problem-solving abilities

Beneficial Skills

Experience with digital validation tools Knowledge of emerging biologics manufacturing technologies Change management expertise Client relationship management skills

Unique Aspects

First biologics contract manufacturer in Singapore offering unique exposure to diverse projects
Opportunity to work with both emerging biotech and established pharmaceutical companies
Access to cutting-edge manufacturing technology and processes
Global network exposure with significant career development potential

Career Growth

Typical progression to next level within 3-5 years based on performance and facility growth

Potential Next Roles

Validation Director Quality Systems Manager Technical Operations Manager Site Validation Head

Company Overview

Lonza

Lonza is a leading global contract development and manufacturing organization (CDMO) with significant presence in biologics manufacturing

Top-tier position in the biologics CDMO market with strong focus on innovation and quality
Strategic importance as first biologics contract manufacturer in Singapore, serving as key APAC hub
Professional environment with strong emphasis on scientific excellence and regulatory compliance
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