Electrical embler HT Team
نُشرت في :
11-01-2025
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About PSC Biotech
Who we are?
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.
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.
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 client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
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 client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Description:
Senior Validation Engineer
The client Validation department performs equipment, utility, facility, cleaning, sterilization and transport validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
- An exciting opportunity has opened in the client validation team for a senior validation engineer.
- In this role, you will be responsible for delivering on the commissioning, qualification, and validation (CQV) program at client site.
- In addition, you will be responsible for planning and executing the sterilization, decontamination, aeration and aseptic processing simulations.
The activities of the Senior Validation Engineer are to:
o Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process across a varied equipment portfolio.
o Development, review and approval of Validation Plans, QRAES, URS, IV/FTs, SATs, Cycle development and PQs etc. for client process equipment in line with GMPs, regulatory requirements, and client standards.
o Liaise with engineering, commissioning and qualification personnel, and external vendors regarding equipment qualification and cycle development best practices ensuring quality by design principles are being followed.
o Manage and execute the equipment validation cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.
o Collate and report on relevant validation data and metrics.
o Assist in the development and improvements of the equipment validation and sterilisation lifecycle process while ensuring continued compliance to all applicable regulations and client standards. In addition, provide input and guidance into multisite and local procedural requirements.
o Coordinate projects and prioritize workload in line with site priorities.
o Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams, Validation and C&Q network and ISPE network discussions to influence industry best practices.
o Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
o Participate in regulatory inspections, regulatory filings and RTQs.
o Attend and contribute to staff meetings and attend appropriate training sessions, as required.
o Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
o Perform validation activities using a paperless validation system and identifying opportunities for improvement.
Requirements
Basic Qualifications:
o Bachelor of Science/Engineering degree or equivalent.
o Knowledge of cGMPs and other worldwide regulatory requirements.
o Problem solving ability and excellent oral and written communications skills
o 5+ years experience in a similar role.
Preferred Experience:
o In depth experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
o In depth experience qualifying filling systems within the sterile manufacturing environment of drug product.
o Previous experience in regulatory inspections.
o Independent, self-motivated, proactive, organized, able to multi-task in project environments and skilled in communication and collaboration.
o Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
#LI-KV1
Basic Qualifications: o Bachelor of Science/Engineering degree or equivalent. o Knowledge of cGMPs and other worldwide regulatory requirements. o Problem solving ability and excellent oral and written communications skills o 5+ years experience in a similar role. Preferred Experience: o In depth experience in equipment qualification and the validation lifecycle process in line with ASTM E2500. o In depth experience qualifying filling systems within the sterile manufacturing environment of drug product. o Previous experience in regulatory inspections. o Independent, self-motivated, proactive, organized, able to multi-task in project environments and skilled in communication and collaboration. o Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. #LI-KV1
نوع التوظيف
دوام كامل
المجال
القسم / المجال المهني
المهارات المطلوبة
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