Senior Pharmaceutical Validation Engineer

Placements24; Stellenbosch; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Provident Fund

Professional development

Paid time off

Wellness programs

Job summary

Placements24 is assisting a leading pharmaceutical manufacturer in Paarl, Western Cape, seeking a Senior Pharmaceutical Validation Engineer to ensure all manufacturing processes, equipment, facilities and utilities meet regulatory standards through rigorous validation. You will lead validation projects, develop master plans, and deliver compliant validation documentation on site.

The ideal candidate has a chemical/mechanical/electrical engineering background with 6+ years in pharma validation,

Qualifications

• Bachelor's degree in chemical/ mechanical/ electrical engineering or related science.
• Minimum 6 years in pharmaceutical validation.
• Proven IQ/OQ/PQ, Process Validation, Cleaning Validation, and CSV experience.
• Strong knowledge of cGMP and regulators (FDA/EMA/SAHPRA).
• Excellent technical writing and attention to detail.
• Ability to lead validation projects and work cross-functionally.

Responsibilities

• Develop, execute, and document validation protocols for manufacturing equipment, processes, cleaning, analytical methods, and facilities.
• Lead validation activities for new equipment installations, process changes, and site expansions.
• Ensure validation activities comply with cGMP and regulatory guidelines (FDA, EMA, SAHPRA).
• Prepare validation master plans (VMPs) and annual revalidation plans.
• Conduct impact assessments and risk analyses related to validation activities.
• Investigate deviations, out-of-specification results, and equipment failures during validation.

Skills

Validation expertise

IQ/OQ/PQ

CSV

cGMP knowledge

Documentation

Project management

Cross-functional collaboration

GAMP 5 familiarity

Education

Bachelor's degree in Chemical/Mechanical/Electrical Engineering or related science

Job description

About the Role

Our client, a key player in the pharmaceutical manufacturing sector, is seeking a highly qualified and experienced Senior Pharmaceutical Validation Engineer to bolster their operations in Paarl, Western Cape . This essential role is responsible for ensuring that all manufacturing processes, equipment, facilities, and utilities meet stringent regulatory requirements and are validated for their intended use. You will lead validation projects, develop comprehensive validation plans, and execute validation protocols to guarantee product quality and patient safety. The ideal candidate will possess a strong engineering or scientific background with extensive experience in pharmaceutical validation, excellent documentation skills, and a rigorous attention to detail. This is a critical opportunity to contribute to the integrity and compliance of our pharmaceutical production. This is a No remote position, requiring full-time on-site engagement in Paarl.

Key Responsibilities

• Develop, execute, and document validation protocols for manufacturing equipment, processes, cleaning, analytical methods, and facilities.
• Lead validation activities for new equipment installations, process changes, and site expansions.
• Ensure all validation activities comply with cGMP, regulatory guidelines (e.g., FDA, EMA), and internal company procedures.
• Prepare validation master plans (VMPs) and annual revalidation plans.
• Conduct impact assessments and risk analyses related to validation activities.
• Investigate deviations, out-of-specification results, and equipment failures during validation and provide solutions.
• Collaborate with cross-functional teams including Engineering, Manufacturing, Quality Assurance, and Quality Control.
• Maintain validation documentation in an audit-ready state.
• Provide technical guidance and training to junior validation engineers and other personnel.
• Stay current with industry best practices and evolving regulatory requirements in pharmaceutical validation.

Requirements

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related scientific discipline.
• A minimum of 6 years of experience in pharmaceutical validation.
• Proven expertise in Equipment Qualification (IQ/OQ/PQ), Process Validation, Cleaning Validation, and Computerized System Validation (CSV).
• In-depth knowledge of cGMP and regulatory requirements from agencies such as the FDA, EMA, and SAHPRA.
• Strong understanding of pharmaceutical manufacturing processes and operations.
• Excellent technical writing skills, with the ability to produce clear, concise, and accurate validation documentation.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Effective project management and organizational skills.
• Ability to work independently and collaboratively in a team environment.
• Familiarity with GAMP 5 guidelines is highly desirable.

Benefits

• Our client offers a competitive salary package, recognizing your expertise in this critical field, along with potential annual performance bonuses.
• Comprehensive medical aid coverage and a Provident Fund are provided for your health and financial security.
• Excellent opportunities for professional development are available through specialized training, workshops, and potential support for professional certifications.
• The manufacturing environment in Paarl, Western Cape is modern and adheres to the highest industry standards.
• Additional benefits include generous paid time off, and employee wellness programs focused on work-life balance.
• This is a vital, full-time position within our compliance and engineering departments.