Senior Validation Engineer - 1754747
Job Title: Senior Validation Engineer (Pharmaceuticals)
Location: Barceloneta, PR
Onsite Job 100%
Company Overview:
ProQuality Network is a prominent player in the pharmaceutical industry, dedicated to delivering high-quality consultants. With a commitment to excellence and a focus on advancing pharmaceutical processes, we are seeking a seasoned Senior Validation Engineer to join our dynamic team.
Position Overview:
As a Senior Validation Engineer reporting to the Quality Department, the successful candidate will lead and execute validation activities across various aspects of our pharmaceutical processes. With a wealth of experience exceeding 10 years in process validations, equipment validation, utilities, Computer Systems Validation (CSV), cleaning validation, and a strong background in backfilling validation projects, this role is instrumental in ensuring compliance and efficiency.
Responsibilities:
- Validation Strategy:
- Develop and implement validation strategies for pharmaceutical processes, ensuring alignment with regulatory requirements and industry best practices.
- Provide expertise in risk-based validation approaches and support project planning.
- Process Validation:
- Lead and execute process validation activities, including protocol development, execution, and final report generation.
- Collaborate with cross-functional teams to ensure the successful validation of pharmaceutical manufacturing processes.
- Equipment and Utilities Validation:
- Oversee equipment and utilities validation activities, ensuring compliance with regulatory standards.
- Develop and execute validation protocols for manufacturing equipment and utilities.
- Cleaning Validation:
- Design and implement robust cleaning validation programs for pharmaceutical manufacturing equipment.
- Conduct cleaning validation studies, analyze results, and recommend necessary improvements.
- CSV (Computer Systems Validation):
- Manage and execute CSV activities for critical computerized systems in the manufacturing environment.
- Ensure that industry standards and regulatory expectations validate computerized systems.
- Experience with MES and DeltaV qualification.
Qualifications:
- Bachelor's or Master's in a relevant scientific or engineering discipline.
- 10+ years of hands-on experience in pharmaceutical validation, focusing on process, equipment, utilities, CSV, and cleaning validation.
- In-depth knowledge of regulatory requirements (FDA, EMA, etc.) and industry guidelines.
- Strong project management skills and the ability to lead cross-functional teams.
- Excellent communication and interpersonal skills.
Project Duration:
This position is for a one-year project with the possibility of extension based on project needs.
If you are a seasoned validation professional with a track record of success in the pharmaceutical industry, we invite you to apply for this impactful role. Please submit your resume to flopez@proqualitynet.com or careers@proqualitynet.com