Hi
Greetings for the day!
This is Sapna Tyagi from Innovative IT Corp,
ROLE : Senior Validation Engineer
LOCATION : Boston, MA On-site
DURATION : 6+ Month Contract + Extension
Visa: USC/GC
managerial references must be included with all candidate resumes**
About the job
A mid-sized life science company in the greater Boston area is looking to add a Validation Lead (Consultant) to their team for the next year. The Validation Lead will report to the Associate Director for Validations and will be actively involved in providing support CAPEX projects for our clients Cell and Gene Therapies program. In this role, you will be responsible for providing Validation technical expertise and guidance on creation, review, and execution of qualification protocols, while collaborating with Global Engineering, Facilities Operations, GIS, QA and PMO.
This project will involve the installation of new equipment trains, qualification of facility (cleanrooms), PPQ and sterilization validation. The Validation Lead will own protocol creation, execution, and report writing for complex systems. Additionally, this position will focus on supporting junior engineers by providing guidance on a regular basis, will support site Validation leadership with project tracking and should have some project management experience.
IDEAL CANDIDATES:
- Minimum Bachelor’s degree in an Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related discipline with 10-12 years of relevant Validation experience or Masters in related field with 8-10 years of Validation experience.
- Experience in writing procedures and developing and executing protocols in GMP industry.
- Understanding and application of technical principles, theories, and concepts in the field, CFR, Annex, GMP, ISO, GAMP, ANSI.
- Prior experience supporting CAPEX projects with guidance and oversight of the installation of new equipment trains, qualification of facility (cleanrooms), PPQ and sterilization validation, protocol creation, execution, and report writing for complex systems.
- Excellent technical problem solving and troubleshooting skills.
- Receptive to change – Adapts (quickly) to changing circumstances.
KEY RESPONSIBILITIES:
- Draft and implement a Site Validation Master Plan (SVMP) in line with company procedures and policies at the start of the project.
- Author URS in collaboration with Engineering and Process Development and other applicable teams.
- Support implementation of validation strategy and approach to qualification of utilities, equipment, and the facility as defined by VCGT Validation management to meet industry regulations and standards.
- Support Project Manage all Validation tasks and ensure timely completion of Validation activities.
- Draft and review IQ, OQ and PQ protocols and execute them when required in compliance with GDP guidelines and internal quality standards.
- Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
- Execute assigned duties on time and pro-actively telegraph delays and other issues to validation management and other relevant stakeholders.
- Comply with all regulatory, corporate, and Quality System policies.
- Completes assigned training and ensures that they are 100% compliant 100% of the time.
- Supports right-the-first time culture for all documents distributed across the organization.
- Performs risk assessments, if required.
Thanks & Regards
Sapna Tyagi
Sr. Technical Recruiter
Innovative IT Corp
Email: Sapna@innovativeITcorp.com Direct (908) 842-0538 EXT. 408
100 Franklin Square Dr Ste 207, Somerset NJ 00873