- Commission, qualify, and validate, GxP facilities, equipment, and utilities in assigned projects.
- Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
- Draft and execute validation documentation such as:
- Validation Project & Master Plans
- Requirement Specifications (URS, DS, FS)
- IQ and OQ Test Scripts
- IQ/OQ/PQ Protocols
- Validation Summary Report
- Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
- Conduct preventative maintenance and perform risk assessments.
- Recommended process improvements where needed ensuring compliance with industry standards.
- Establish validation standards and develop performance testing and quality control measures.
- Execute process equipment and clean room validation.
- Clearly communicate all progress, updates, and action steps for assigned projects. Collaborate with multiple departments on assigned project activities and deliverables.
- Additional duties as assigned.
- Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
- 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
- Sound industry knowledge, project proficiency, and autonomy expected.
- Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
- Understands current risk-based validation approaches.
- Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
- Experience with system impact assessment and risk assessment.
- Good knowledge of the code of GMP and PIC/S code.
- Previous experience in the Life Sciences Industry is required.
- Previous experience in GxP Industries are required.
- Must be adaptable, customer service oriented, have a positive attitude.
- Excellent organizational skills.
- High attention to detail.
- Must have strong written and verbal communication skills.
-
Verification & Validation Engineer
4 days ago
Leidos Adelaide, Australia Full timeJob Description · We have a permanent full-time opportunity based in Adelaide SA for a Verification & Validation (V&V) Engineer to join our team & support the establishment of the V&V engineering environment & the planning & conduct of incremental system verification. · In this r ...
-
Psc Biotech Adelaide, Australia Full timeAbout Us · PSC Biotech provides essential services to the life sciences industry to ensure the development, manufacturing, and distribution of healthcare products meet the highest standards and regulatory requirements. · With a global team of professionals across North America, E ...
-
Psc Biotech Corporation Adelaide, Australia Full timeJob Description · PSC Biotech provides essential services to the life sciences industry to ensure the development, manufacturing, and distribution of healthcare products at the highest standards and in compliance with regulatory requirements. · Our global team of skilled professi ...
-
PSC Biotech Adelaide, AustraliaPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our clients' success, a ...
-
PSC Biotech Adelaide, AustraliaJob Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our c ...
-
Trade Assistant
1 day ago
Saunders International Adelaide, Australia**WHO WE ARE** · Operating successfully and continuously for over 70 years, Saunders' considerable knowledge and experience ensures we provide to our clients a range of innovative solutions for their individual project specifications. We have an extensive portfolio of projects, d ...
-
Riggers / Crane Operators
1 day ago
Saunders International Adelaide, Australia**WHO WE ARE** · Operating successfully and continuously for over 70 years, Saunders' considerable knowledge and experience ensures we provide to our clients a range of innovative solutions for their individual project specifications. We have an extensive portfolio of projects, d ...
-
Electrical Building Services
4 days ago
KBR Adelaide, Australia**Title**: · Electrical Building Services - Team Lead · Following significant project wins across the business, an exciting opportunity has opened for an experienced engineer to lead electrical building services team in Adelaide. · As the Electrical Building Services Team Lead, y ...
-
Design Manager
1 week ago
Phillip Riley Adelaide CBD, AustraliaPerfect opportunity for a Design Engineer to transition into a project lead role · - Strong pipeline of Regulated and Contestable Packages of Work · - Rewarding culture and benefits package · We are currently working in partnership with Adelaide's Electrical Transmission Company ...
-
Trainer & Assessor - Electrical
5 days ago
Verbrec Limited Adelaide, AustraliaFull time - Permanent opportunity based in Adelaide · - Flexible & dynamic team environment with salary and benefits to match · - Join a growing ASX listed RTO with exciting opportunities · **About Us** · Competency Training (RTO#31299) is an industry leading electrical training ...
-
Dual Trade e
1 week ago
ICE Engineering & Construction Adelaide CBD, Australia**ICE Engineering and Construction**, part of the E&A Limited group of companies, is a specialist Electrical and Instrumentation Installation company that operates in the Heavy Industrial sectors. · Due to our current requirements we are looking for experienced industrial **Dual ...
-
Engineering Manager
1 week ago
Kelly Tillage Adelaide CBD, Australia**Engineering Manager**: · - **Join a rapidly growing global company headquartered in SA**: · - **Lead the technical development of sustainable AgTech machinery with an innovation focus** · **About Kelly Tillage** · At Kelly Tillage we are passionate about sustainable agriculture ...
-
Digital Engineering Coordinator
3 days ago
KBR Adelaide CBD, Australia**Title**: · Digital Engineering Coordinator · Do you want to take your **Digital Engineering skills** to the next level? · **The Opportunity** · We are actively seeking an experienced **Digital Engineering Coordinator** to join our team at the KBR South Australia office. In this ...
-
Scheduler
1 week ago
Babcock International Adelaide CBD, Australia**Scheduler**: · - Country/Region: Au- City: Adelaide**About the Role** · This is an exciting career development opportunity to join Babcock's Mission and Support Systems portfolio You will become an integral member of our high-performing Defence team within a key maritime progra ...
-
Maintenance Coordinator
3 days ago
UniLodge Australia Pty Ltd Adelaide, AustraliaFull time permanent opportunity to work with an industry leader · - Varied role - perform internal and grounds maintenance tasks · UniLodge specialise in student accommodation and have been an industry market leader since 1996. The UniLodge Group manages a diverse portfolio of cl ...
-
Shed Install Team Leader Full Time
1 week ago
Ciampa Engineering Adelaide CBD, Australia Full time**Job Advert** · **Position**: Shed Install Team Leader, Full time · **Company**: Ciampa Engineering and Crane Hire · **Location**: Adelaide · Are you an experienced and motivated shed installer with a natural ability to lead and inspire others? Are you looking for an opportunity ...
-
Metal Fabricator
4 days ago
Frontline Human Resources Adelaide, Australia**About the Company** · Frontline Human Resources are a national agency with over 20 years of specialised experience in electrical and plumbing apprenticeships. Since 2001 we have hired and trained over 2,000 apprentices, matching them with work placements and companies large and ...
-
Cyber Security Analyst
1 week ago
Comunet Pty Ltd Adelaide CBD, Australia**About Comunet** · **The Opportunity** · We specialise in Cyber Security (GRC, Advisory, Technical / Vulnerability Assessments, Security Incident Management, Technical Control Implementations), Cloud (Office 365, AWS & Azure), and Modern Application Development.As a Cyber Securi ...
-
Junior Data Analyst
4 days ago
Peoplebank Adelaide CBD, AustraliaLocation: · - Adelaide CBD- Job Type: · - Permanent- Posted: · - about 2 hours ago- Contact: · - Matthew Chatterton- Discipline: · - Business Intelligence / Data Analytics · - Reference: · Peoplebank are currently recruiting for **two** **Junior Data Analysts** to join a **Govern ...
-
SA Health Adelaide, Australia**Job no**: 861318 · **Work type**: Full time · **Location**: Adelaide CBD · **Categories**: Allied and Scientific Health, Corporate Services, Technical · - **Department for Health and Wellbeing - Corporate Services - SA Biomedical Engineering**: · - **Multiclass - Full Time / Te ...
Commissioning Qualification Validation Engineer - Adelaide, Australia - PSC Biotech Corporation
Description
Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia-Pacific and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech, it's about more than just a job—it's about your career and your future.
Your Role We are looking for a Commissioning, Qualification, and Validation (CQV) Engineer . The CQV Professional would work alongside a talented PSC Biotech Team in an exciting, developing, and diverse biotechnology landscape.
Requirements
