Title:  Specialist, Validation

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people in need. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines. 

Hikma, intends to recruit an Specialist, Validation (m/f) to integrate Validation - New Projects Department, on-site work.

Main Responsibilities:

• Plans and executes qualification and validation activities for equipment, utilities, facilities, and processes in accordance with approved protocols, GMP requirements, and applicable regulatory guidelines (FDA, EMA, ICH), and supports related activities as required
• Plans the scheduling, preparation, execution, and documentation of validation activities ensuring alignment with approved validation plans and timelines, and supports related activities as required.
• Plans and executes documentation of internal and external validation field activities as per approved protocols, and supports related activities as required.
• Issues the drafting of documentation of qualification and validation protocols and reports (IQ/OQ/PQ, process validation), including their execution data analysis and preparation of validation summaries, and supports related activities as required.
• Issues the drafting and revision of department‑applicable Standard Operating Procedures (SOPs) under guidance and approval of authorized roles.
• Support the verification of conformance of activities performed by external validation contractors against approved procedures and processes.
• Support the maintenance of Validation Master Plans (VMPs) by assisting in routine reviews and contributing to updates as requested by senior team members.
• Plans the coordination and execution with external suppliers and manufacturers for FATs, SATs, and qualification activities, including documentation preparation, scheduling, tracking actions, and escalating issues to senior validation staff. 
• Plans and executes validation activities for sterile injectables at the Portugal site by executing defined tasks, maintaining compliant documentation, and providing day‑to‑day technical support — escalating complex or strategic matters to the Validation Manager. 
• Collaborate with cross‑functional teams (Quality Unit, Manufacturing, Engineering, Maintenance) to support timely execution of validation and qualification projects. 
• Plans and supports the training and day‑to‑day guidance of junior validation personnel, in alignment with approved training plans.  
• Issues and supports investigations of validation-related deviations by collecting evidence, drafting investigation records, performing initial root‑cause analysis using approved methods, proposing corrective and preventive actions (CAPA) for senior review, and tracking effectiveness checks to closure. 
• Support tracking of agreed CAPAs and effectiveness checks to closure, in coordination with senior validation and quality staff. 
• Maintain up‑to‑date knowledge of GxP requirements, validation best practices, and applicable regulatory expectations. 
• Ensure adherence to global and local standards (EMA, FDA, MHRA, and local authorities) in the execution of validation activities. 
• Support internal and external audits by preparing and retrieving validation documentation, responding to routine validation queries, and supporting senior staff during discussions with auditors and inspectors. 
• Support continuous improvement initiatives related to validation processes, documentation practices, and execution efficiency, as defined by management objectives. 

Profile:

• Bachelor's degree or equivalent in technical/science (Minimum)
• Degree in Engineering in Mechanical, Electro technical or Chemistry (Preferred) 
• Demonstrated experience in validation projects
• Demonstrated computer skills including Word, Excel and CAD
• English Intermediate Level
• Knowledge of risk-based validation approaches and data integrity principles
• Familiarity with electronic validation documentation systems

We offer:

• Direct contract with Hikma
• Salary appropriate to the functions performed
• Life insurance
• Health insurance
• Annual Performance Bonus
• High career prospects

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day