Senior Validation Engineer
Share
Job Location:
Monthly Salary:
Experience Required:
Posted on:
5 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.
Overview:
Looking for senior Validation Engineer with team lead experience reporting to the Commissioning Qualification and Validation Manager day to day technical direction may be delegated to the Engineering Validation Team Lead as required and is responsible for fulfilling validation activities in a GxP regulated environment including implementation of laboratory systems new manufacturing equipment/processes and changes to existing equipment/processes.
Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain cutting-edge manufacturing processes and sites provide quality assurance and quality control to ensure we meet regulatory standards and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Requirements
Responsibilities:
- In collaboration with plant support functions assist with planning set up and implementation of Analytical Instrument Qualification Facilities Utilities Equipment (FUE) Qualification and Process Validation programs.
- Execute (protocol generation execution and final package preparation) Validation activities related to the various Validation disciplines e.g. FUE Qualification CSV New Product Introductions and Change Control.
- Develop validation plans for specific system implementation projects.
- Support the establishment of site validation policies through development generation and implementation of site validation master plans guideline documents and standard operating procedures.
- Prepare and track to completion any assigned change requests deviations quality events and associated CAPAs.
- Develop and demonstrate an active approach to safety industrial hygiene environmental and regulatory compliance.
- Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured validation techniques/approaches and systems utilized
- Lead and represent validation in multi-departmental meetings and project teams.
- Identifies and implements improvements to the Engineering Validation systems.
- Coordinate validation activities involving cross-functional multi-departmental teams including: Manufacturing Process Sciences Process Development Quality Control Quality Assurance Regulatory Affairs and others.
- Drug Product-specific. Drug Product experience is still a preference but we will look at other validation experience as well (e.g. Cleaning Steam Temperature Mapping).
Other duties as assigned
Required Skills:
Drug Product-specific. Drug Product experience is still a preference but we will look at other validation experience as well (e.g. Cleaning Steam Temperature Mapping). Looking for senior Validation Engineer Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.
Required Education:
Drug Product-specific. Drug Product experience is still a preference but we will look at other validation experience as well (e.g. Cleaning Steam Temperature Mapping). Looking for senior Validation Engineer Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.
Company Industry
IT Services and IT Consulting
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
