Validation Engineer

Do you have expertise in leading a validation team in aseptic manufacturing in the areas of process validation, sterilisation, cleaning, media fills, and contamination control? Would you like to apply your expertise and join an organisation that follows science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!
 

We are looking for an experienced Validation Engineer, with perseverance and natural curiosity to join the Validation team at our manufacturing site in Macquarie Park:

• An exciting full-time 12 month fixed term opportunity
• Facilitate stakeholder engagement with your strong service orientation

About AstraZeneca

Join a team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

The North Ryde manufacturing facility remains an important center for both AstraZeneca and manufacturing in Australia.  We are proud of our long heritage in Australia, where for more than 65 years, AstraZeneca has been providing medicines to treat many cancers and chronic diseases, saving lives and extending life for millions of Australians.

Benefits

• An extra paid day off every month!
• On-site car park and site staff canteen
• Gym membership

What you’ll do

Reporting to the Validation Manager, the Validation Engineer will manage projects in and provide guidance to Engineers performing validation and support their validation function.

This role involves:

• Write/develop/review and provide technical and compliance input to validation protocols and reports (IQ/OQ/PQ/PPQ) for Projects, Revalidation, Change Control, or CAPA which meet the requirements of established Testing Plans.
• Perform data analysis to evaluate process capability and make recommendations for process improvement where necessary
• Develop risk assessments associated with validation activities
• As an SME, assist with the review of validation test documents relating to Change Control and CAPAs
• Coordinate project and/or production staff, activities, and schedules for all assigned projects that fall in line with business objectives.
• Develop and implement work action plans to ensure projects are delivered, meeting project timelines.

Essential for the role

• Tertiary Qualifications in science, engineering, or Quality related discipline.
• Previous experience in a pharmaceutical or related industry manufacturing environment in Production, Engineering, or Quality Assurance
• Minimum 2 years in Validation.
• Attention to Detail, Analytical Thinking, Drive and Determination, Multi-Tasking.
• Test Protocol development & Report writing
• Clear and effective communication with relevant departments, Experience with working in a multidisciplinary environment
• Problem-Solving and conducting risk assessments.
• Good time management skills and ability to work with multiple tasks and changing priorities
• Commitment and passion for Compliance and Quality, with attention to detail and the ability to speak up while remaining un-influenced.
• Leadership in areas of technical expertise.
• Computer literacy and experience using Microsoft applications and familiarity with SAP and eQMS

Desirable for the role

• Knowledge of regulation requirements within the Pharmaceutical Manufacturing Environment
• Knowledge of Sterilisation, Cleaning, Computer and Process Validation
• PC Skills particularly with Microsoft applications of Word, Excel, PowerPoint.

Why AstraZeneca

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.  

AstraZeneca in Australia has been formally recognized as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence in our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high-performing, inclusive, and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work 

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have a seat available, and we hope it’s yours.
• If you’re curious to know more then please reach out to Dia Dutta.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Our website https://www.astrazeneca.com.au/

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.