Job Description

Description:
Start ASAP
Duration: 12 months from Start Date
RTR and PESV mandatory
Teva Grade 10
Function: Senior Validation Expert:
A highly skilled and experienced Senior Validation Engineer with expertise in validation/re-qualifications of Equipment/System including Project work/Changes/CAPAs. In addition knowledge of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies & validation related to within the pharmaceutical industry. You will play a critical role in ensuring compliance with regulatory requirements and industry standards while optimizing operational efficiency and product quality.
Key Responsibilities:
- Lead and participate in equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Support execution of validation protocols/plans for Validations/Re-qualifications of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies or any other manufacturing assets or utilities
- In case of deviations; Document, notify & co-ordinate for corrective action, and close out.
- Provide technical expertise and guidance on validation-related issues to project teams and stakeholders.
- Collaborate with cross-functional teams to ensure validation activities align with production schedules, project timelines and quality expectations.
- Conduct risk assessments and impact analyses related to validation activities and propose appropriate mitigation strategies.
- Draft, review and assess validation data, deviations, and change controls to ensure compliance with regulatory requirements and Teva internal quality standards.
- Draft, review and assess periodic review data/ report.
- Ensure adherence to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) during validation activities.
- Support during internal/external inspections/Audits in addition to representing relevant topics as an SME & having solid knowledge to communicate with authorities.
- Mentor and provide training to junior validation team members, sharing knowledge and best practices.
Profile:
- Bachelor's or higher degree in a relevant scientific or engineering discipline.
- Minimum 4~5 years of experience in validation/CQV within the pharmaceutical industry,
- Knowledge of experience in GMP including V-Model & SDLC methodologies.
- Strong analytical, problem-solving, organizational and project management skills.
- Team player with attention to detail and strong can-do mentality
- Excellent written and verbal communication skills, including the ability to effectively collaborate with multidisciplinary teams. Enable Skills-Based Hiring No
Is this an IT position?
Additional Details

• Manager's Requested Bill Rate : (No Value)
• Shore Options Available for this Position : Onshore Only
• Critical Position? : No
• Is this an IT position? : No
• Does the position allow for the worker to be virtual/remote? : No
• Shift Type : Standard Business Hours
• NL Shift Type : NA
• Overtime Applicable? : No
• White/ Blue Collar Worker? : White Collar
• Project Code : (No Value)

Skills Required