Senior CQV Engineer MS&T
Share
Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
About PSC Biotech
Who are we
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
The Specialist Engineering MS&T Q&V will be an active member within the cross functional team providing support and guidance and will strive for technical excellence to ensure the success of the Q&V team.
Responsibilities:
Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
Participate in CSV Validation Lifecycle processes Qualification (RS/QAP/UAT etc) CSV Periodic Reviews for Equipment and Systems.
Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements including ownership as relevant.
Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
Execute/Participate in change controls and other compliance related tasks e.g. non-conformances.
Support regulatory audits
Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities
Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
Support lead or guide others in CQV projects.
Requirements
Qualifications
Experience in a GMP environment essential.
Experience
Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations with experience of successfully delivering technical projects.
Knowledge of Regulations and applicable standards for Quality Safety Regulatory
Skill Set
Demonstrated capability of working and collaborating across multiple functional teams.
Demonstrated capability to deliver results RFT in an FDA/HPRA Regulated production environment.
Stakeholder management of multiple decision makers corporate colleagues cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
Required Skills:
Qualifications Hon. Degree in a Science or Engineering discipline. Experience in a GMP environment essential. Experience Minimum 5 years experience in a similar role. Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations with experience of successfully delivering technical projects. Knowledge of Regulations and applicable standards for Quality Safety Regulatory Skill Set Demonstrated high level of complex problem solving and attention to detail. Demonstrated capability of working and collaborating across multiple functional teams. Demonstrated capability to deliver results RFT in an FDA/HPRA Regulated production environment. Stakeholder management of multiple decision makers corporate colleagues cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
Company Industry
IT Services and IT Consulting
Key Skills
- APIs
- C/C++
- Computer Graphics
- Go
- React
- Redux
- Node.js
- AWS
- Library Services
- Assembly
- GraphQL
- High Voltage
