Process Lead - Product Life Cycle (Sterile API Drug Substance)

Julphar; United Arab Emirates; On-site; AED 120,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in the UAE seeks an experienced validation expert to oversee processes for sterile facilities. The ideal candidate must hold a degree in pharmacy or related fields, with 8–10 years of experience in pharmaceutical validation. Responsibilities include leading validation efforts, investigating incidents, and ensuring compliance with regulatory standards. Join us to make a positive impact through innovative solutions.

Qualifications

• 8–10 years of experience in pharmaceutical validation with a focus on solid oral dosage forms.
• Proven expertise in process, cleaning, packaging, transport validation, and hold time studies.
• Sound knowledge of EU GMP, FDA, WHO, and ICH Q8–Q10.

Responsibilities

• Responsible for cleaning validation documents and execution activities for Sterile Facilities.
• Lead packaging component and process validation for sterile dosage forms.
• Investigate incidents and non-conformances related to validation.

Skills

Accountability and ownership

Ability to prioritize and multi-task

Good communication skills

Adaptability to changing situations

Technical expertise in validation

Education

Bachelor’s or master’s degree in pharmacy, chemistry, biotechnology, or related field

Job description

At Julphar, we are on a journey of culture transformation and our mission is to provide a better quality of life for the entire family by delivering best‑in‑class solutions and real value with compassion and professionalism. Our core values—Respect, Collaboration, Innovation, Integrity, and Compassion—combined with a focus on diversity, inclusion, and equal opportunities, are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable talent, create a healthy work environment, and accomplish our goals through world‑class research and the compassion and commitment of our employees.

Key Responsibilities

• Responsible for the process and cleaning validation documents and oversight of the execution activities for the Sterile Facilities (Biotech, Liquid Injectable, Lyophilized, and Sterile powder filling).
• Responsible for the Process Validation of Sterile Manufacturing and API biological drug substance.
• Familiar with the Biosimilars API Drug substance processing and fill finish.
• Aware of the standards mentioned as per EU annex‑1 requirements. Familiar with the Cleaning Validation of API drug substance as per the PDA TR 29.
• Responsible for designing aseptic process simulation studies and preparing protocols and reports.
• Support lifecycle monitoring and continued process verification (CPV) based on trend data and product performance.
• Design and execute cleaning validation protocols using a risk‑based approach and scientifically justified acceptance criteria (e.g., MACO, PDE‑based limits).
• Address cleaning of equipment used in multiproduct facilities and define appropriate cleaning frequencies.
• Conduct in‑process, bulk product, and clean/dirty equipment and area hold time studies to establish validated holding periods and ensure no impact on product quality.
• Justify clean hold and dirty hold times as per industry guidance and support with microbial and visual inspection data.
• Lead packaging component and process validation for sterile and biotech dosage forms including vials and ampoules to ensure container‑closure integrity, sterility assurance, label accuracy, and compliance with global regulatory expectations.
• Perform risk‑based cross‑contamination assessments in compliance with EU and WHO guidelines.
• Design and execute transport validation protocols including temperature mapping, route qualification, and simulation studies to validate packaging during shipping and storage.
• Familiar with the filter validation requirements in the sterile process.
• Responsible for the visual inspection qualification process.
• Investigate incidents, OOS, returns, goods, and all manufacturing‑related non‑conformances with respect to validation.
• Review change controls, CAPAs, and deviations related to qualification and validation. Act as Quality general in EQMS to complete the actions associated with qualification and validation activities.
• Monitor CAPA effectiveness related to validation.

Core Competency

• Highly result‑oriented with a strong sense of accountability and ownership.
• Ability to prioritize, multi‑task, and work effectively under pressure to meet deadlines.
• Good communication, interpersonal, and collaboration skills.
• Highly disciplined and self‑motivated to learn new lessons and implement them at the workplace.
• Technical expertise required for the qualification and validation in sterile and biotech plants.
• Good implementation skills and easily adapt to changing situations.
• Must be able to work in a cross‑functional environment interacting with other internal and external departments.
• Must be able to communicate technical, scientific, and regulatory information, both written and verbally.

Qualification / Functional Knowledge

• Bachelor’s or master’s degree in pharmacy, chemistry, biotechnology, or related field.
• 8–10 years of experience in pharmaceutical validation with a focus on solid oral dosage forms.
• Proven expertise in process, cleaning, packaging, transport validation, and hold time studies.
• Sound knowledge of EU GMP, FDA, WHO, ICH Q8–Q10, Annex 15, PICS, and GAMP 5.
• Strong command of QRM principles, data integrity, PDE/MACO calculations, and QMS documentation.
• Experience with regulatory inspections (USFDA, MHRA, EU, TGA, ANVISA) preferred.

Excellent leadership, communication, documentation, and cross‑functional coordination.

We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar.