Are you an experienced pharmaceutical validation professional with expertise in Computer System Validation (CSV) and GxP compliance? The Searle Company, one of Pakistan’s leading pharmaceutical organizations, is offering an outstanding career opportunity for the position of Associate Manager – Validation & Qualification (CSV) at its Karachi Plant (SITE).

This role is ideal for professionals who have extensive experience in validating computerized systems used in pharmaceutical manufacturing, quality control, laboratory operations, and enterprise systems. The selected candidate will play a vital role in ensuring that computerized systems meet regulatory requirements, maintain data integrity, and comply with Good Manufacturing Practices (GMP) and GAMP 5 guidelines.

If you have a strong background in Computer System Validation (CSV), pharmaceutical regulations, SAP S/4HANA, LIMS, and computerized quality systems, this is an excellent opportunity to build your career with one of Pakistan’s most respected pharmaceutical companies.

About The Searle Company

The Searle Company Limited is one of Pakistan’s most recognized pharmaceutical manufacturers, known for producing high-quality medicines across a wide range of therapeutic segments. The company has built a reputation for innovation, regulatory compliance, and commitment to improving healthcare through world-class manufacturing practices.

Working at Searle provides professionals with the opportunity to contribute to advanced pharmaceutical operations while gaining exposure to international quality standards, computerized systems, and regulatory best practices.

Why Work at Searle?

• Excellent career growth opportunities
• Exposure to international pharmaceutical standards
• Modern manufacturing facilities
• Collaborative work environment
• Continuous professional development
• Competitive compensation and benefits
• Opportunities to work with cutting-edge pharmaceutical technologies

Job Details

Job Overview

The Associate Manager – Validation & Qualification (CSV) is responsible for validating computerized systems used throughout pharmaceutical operations to ensure compliance with GMP, GAMP 5, and applicable regulatory standards.

The successful candidate will prepare and execute validation protocols, assess software changes through formal change control processes, and ensure computerized systems consistently operate as intended while maintaining complete data integrity.

This role requires collaboration with Quality Assurance, Information Technology, Engineering, Production, Laboratory, Regulatory Affairs, and external vendors to support compliant pharmaceutical manufacturing operations.

Key Responsibilities

The selected candidate will perform a variety of validation and qualification activities, including:

• Validate GxP computerized systems according to GAMP 5 guidelines.
• Develop validation strategies for new computerized systems.
• Prepare validation master plans where applicable.
• Draft, review, and approve validation protocols.
• Execute installation, operational, and performance qualification activities.
• Prepare comprehensive validation reports.
• Review system documentation for regulatory compliance.
• Evaluate software upgrades and patches.
• Assess software implementations through the Change Control process.
• Perform risk assessments for computerized systems.
• Verify compliance with data integrity requirements.
• Ensure electronic records meet applicable regulatory expectations.
• Collaborate with IT and Quality Assurance teams.
• Coordinate with software vendors during implementation.
• Support internal and external audits.
• Maintain validation documentation throughout the system lifecycle.
• Review user requirement specifications (URS).
• Review functional and design specifications.
• Monitor validation project timelines.
• Support inspection readiness activities.
• Ensure computerized systems remain in a validated state.
• Participate in continuous process improvement initiatives.
• Train users on CSV-related procedures when required.

Educational Requirements

Candidates should possess one of the following qualifications:

Required Education

• Pharm D
• MSc Chemistry
• MSc Applied Chemistry
• BE Computer Science
• BS Computer Science
• Software Engineering
• Computer Systems Engineering

Candidates with additional certifications in pharmaceutical quality systems, validation, or regulatory compliance will have an added advantage.

Experience Requirements

Applicants should have:

• 6–8 years of proven experience in Computer System Validation (CSV).
• Experience within the pharmaceutical industry.
• Hands-on involvement in computerized system implementations.
• Experience preparing validation documentation.
• Knowledge of qualification lifecycle management.
• Experience working with Quality Assurance teams.
• Familiarity with pharmaceutical manufacturing processes.
• Experience supporting regulatory inspections.

Professionals with experience in multinational pharmaceutical organizations may receive additional consideration.

Required Technical Skills

The ideal candidate should possess expertise in:

Computer System Validation (CSV)

• Validation lifecycle management
• GAMP 5 methodology
• Validation documentation
• Risk-based validation
• Validation testing
• Protocol execution

Regulatory Compliance

• Good Manufacturing Practices (GMP)
• GxP regulations
• Data Integrity (ALCOA+ principles)
• Change Control
• CAPA
• Quality Management Systems

Enterprise Systems

Experience with:

• SAP S/4HANA
• Laboratory Information Management Systems (LIMS)
• Manufacturing Execution Systems (MES)
• Electronic Document Management Systems (EDMS)
• Quality Management Software
• Other GxP computerized systems

Documentation Skills

The candidate should be able to prepare:

• Validation Protocols
• Validation Reports
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Design Specifications (DS)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Traceability Matrices
• Risk Assessment Reports

Essential Soft Skills

Success in this position requires:

• Strong analytical thinking
• Excellent documentation skills
• Attention to detail
• Problem-solving abilities
• Project management capabilities
• Effective communication
• Team collaboration
• Leadership potential
• Time management
• Decision-making skills
• Regulatory awareness
• Continuous learning mindset

Understanding Computer System Validation (CSV)

Computer System Validation is a documented process that demonstrates computerized systems consistently perform according to predetermined specifications while meeting regulatory requirements.

Within pharmaceutical manufacturing, CSV ensures that systems supporting production, laboratory testing, quality management, and data processing are reliable, secure, and compliant.

Examples of systems requiring validation include:

• Enterprise Resource Planning (ERP) systems
• Laboratory Information Management Systems (LIMS)
• Quality Management Systems
• Electronic Batch Record Systems
• Manufacturing Execution Systems
• Stability Management Systems
• Electronic Document Management Systems

Professionals in this role help ensure patient safety by maintaining the integrity, reliability, and compliance of these critical systems.

Career Growth Opportunities

Joining The Searle Company opens pathways to advanced positions such as:

• Validation Manager
• CSV Lead
• Quality Systems Manager
• Computerized Systems Compliance Manager
• Quality Assurance Manager
• Regulatory Compliance Manager
• IT Quality Manager
• Digital Validation Specialist
• Global Validation Consultant

As pharmaceutical manufacturing continues to embrace digital transformation, experienced CSV professionals are increasingly in demand both locally and internationally.

Tips for Preparing Your Application

To improve your chances of selection:

• Update your CV with recent validation projects.
• Highlight experience with SAP S/4HANA, LIMS, or other GxP systems.
• Mention specific validation lifecycle activities you have managed.
• Include experience with IQ, OQ, PQ, and validation documentation.
• Demonstrate your knowledge of GAMP 5, GMP, and data integrity principles.
• Quantify achievements, such as successful system implementations, audit support, or compliance improvements.
• List any certifications related to pharmaceutical quality, validation, or project management.

Why This Opportunity Stands Out

This role offers the chance to work on mission-critical pharmaceutical systems that directly support product quality and patient safety. You’ll collaborate with multidisciplinary teams, gain exposure to modern digital technologies, and contribute to maintaining compliance with global regulatory expectations.

Professionals with a passion for quality, technology, and regulatory excellence will find this position both challenging and rewarding.

How to Apply

Interested and eligible candidates should send their updated resume to:

Email: [email protected]

Application Deadline

August 20, 2026

Email Subject Line

Associate Manager – Validation & Qualification (CSV)

Before submitting your application, ensure that your resume:

• Highlights relevant CSV experience.
• Includes pharmaceutical industry exposure.
• Lists experience with SAP S/4HANA, LIMS, or other GxP systems.
• Demonstrates expertise in GMP, GAMP 5, and data integrity.
• Is updated with your latest qualifications and professional achievements.

Final Thoughts

The Associate Manager – Validation & Qualification (CSV) position at The Searle Company represents an exceptional opportunity for experienced pharmaceutical professionals seeking to advance their careers in Computer System Validation and regulatory compliance.

With responsibilities spanning computerized system validation, qualification, change control, data integrity, and GxP compliance, this role offers significant exposure to advanced pharmaceutical technologies and internationally recognized quality standards. If you possess 6–8 years of CSV experience, a relevant technical or scientific qualification, and expertise in GAMP 5, SAP S/4HANA, or LIMS, this opportunity can serve as a major milestone in your professional journey.

Frequently Asked Questions (FAQs)

1. Where is this position located?

The job is based at The Searle Company’s Karachi Plant (SITE).

2. What qualifications are required?

Candidates should hold a Pharm D, MSc Chemistry, MSc Applied Chemistry, or a BE/BS in Computer Science, Software Engineering, or Computer Systems Engineering.

3. How much experience is needed?

Applicants must have 6–8 years of proven Computer System Validation (CSV) experience within the pharmaceutical industry.

4. Which systems should candidates be familiar with?

Hands-on experience with SAP S/4HANA, LIMS, and other GxP computerized systems is highly desirable.

5. What is the application deadline?

The last date to apply is August 20, 2026. Send your updated resume to [email protected] with the subject line “Associate Manager – Validation & Qualification (CSV).”