Job Description
About PSC Biotech
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.
Job Title: CQV Engineer
Role Description:
As part of a significant expansion of the client site, an exciting opportunity has come to join the science, engineering/manufacturing & commercialization team to support the high potency facility from construction, project phase to a fully operational facility delivering life-saving products to patients.
The Area:
There are 4 broad technical areas that will require the leadership of experienced, energetic, and committed engineers:
1. Cleaning – Parts Washer
2. Vial and Syringe (and cartridge) filling operations – Glass handling, Tray & Tub handling, Drug Product Filling and Parenteral Product Visual Inspection
3. Vial and Syringe Sterility operations – Isolators, VHP
4. Fill Finish ancillary equipment – FIT, GIT, Tube Welders/ Sealers
The successful candidate will need to have demonstrated in-depth experience in 3 or more of these areas.
Requirements
Role Functions:
The successful candidate will be involved in the project from Detailed Design, Construction, Site Acceptance Test (SAT) at the earliest, responsible for C&Q deliverables and follow assigned systems through to the Equipment Performance Qualification, Validation, and Product PQ – including filing with regulatory bodies.
1. Factory Acceptance Test – Attendance, hands-on support and C&Q Oversight
2. Installation to Mechanically Complete – C&Q Oversight
3. Commissioning & Qualification – Hands-on support & Oversight throughout project lifecycle
4. Cycle Development – Execution of Cycle Development pre and post OQ phases
5. Performance Qualification – Responsibility for/Execution of all Performance Qualification testing
The Expectations:
1. Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests.
2. Act as C&Q SME on the equipment within the assigned area.
3. Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
4. Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
5. Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
Experience, Knowledge & Skills:
1. This role requires an experienced individual with a minimum of 3 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
2. A self-starter and results-focused individual with strong contemporary knowledge and the ability to work independently and on multidisciplinary teams.
3. Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science.
4. Relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
Qualifications & Education:
This role requires an experienced individual with a minimum of 3 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices. Applicants with less than 3 years of direct experience may be considered for future, more junior roles.
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