Validation Engineer

at  Viatris

Alphapharm Pty. Ltd.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
You manage pharmaceutical Plant, Equipment, and Facility projects from small, bespoke enhancements, to entire pharmaceutical manufacturing systems.
You operate with a combination of practical hands-on application and expert documentation development with all stakeholders to improve efficiency, cost, and compliance within our manufacturing site.
You work collaboratively with Departmental Managers / Project Owners to deliver projects from requirements definition to validation completion, ensuring all projects are delivered within site timelines, cost, safety, compliance, and quality requirements.

You will possess the following:

• a Bachelor’s degree in Engineering in Mechanical, Electrical or a combination of both disciplines
• High proficiency in Project Management software, MS Project.
• 2 years’ experience within the Pharmaceutical Industry (desirable)
• Experience with AutoCad or other drafting
• A high degree of technical aptitude in large volume automated manufacturing processes

Responsibilities

• Project Management - work with department managers and other project stakeholders to manage projects of varying sizes and types, end to end
• Equipment / systems selection – develop and document equipment / system requirements, assess alternative solutions, and contribute to CAPEX / CPR preparation and submission
• Facilities and utilities management - design, modification, installation and commissioning.
• Equipment validation - develop validation / commissioning documentation, and be involved in the installation and qualification of new equipment

Duties

• Development and management of Project Plans/Programs including schedule and cost reports for the overall management of projects and communication to relevant stakeholders.
• Liaise with department Managers, site SMEs, and external suppliers to ensure successful project scope and delivery to meet schedule and cost targets
• Contractor management and supervision
• Ensure projects meet site compliance requirements and processes including change control and validation to cGMP and Viatris standards
• Review technology and initiate innovative process and technology improvements
• Assist and support equipment / system owners with technical issues as required
• Communicate and endorse safety practices, ensure projects meet all site and safety standards and requirements e.g., JSA/SWMS Permits etc., monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives
• Carry out all other duties as directed by management

Viatris Benefits

• Employee rewards and discount platform
• Annual wellness allowance
• Recognition programs
• State of the art canteen onsite with a variety of subsidised food options
• Benefits for health and financial wellness
• Corporate deals with vendors including superannuation fund, health insurance and others
• Viatris Product loyalty program
• Free annual flu vaccination
• 2 days of paid volunteer leave per annum
• Additional paid parental leave
• Career and development planning for continuous growth and learning
• Retirement savings plans
• Annual leave loading, as well as paid additional bereavement leave

Culture
Viatris has been named in Forbes’ World’s Best Employers 2022 list. We have now received this recognition in each of our first two years – and for 2022, we are ranked in the top 10% of the 800 global employers who made the ranking.
Viatris strives to create a positive, productive work environment where integrity, dignity and mutual respect for all is ingrained each and every one of us.
Together, we are building a highly inclusive organization where employees are welcome to bring their best, authentic selves to work every day.
Our goal is to provide a safe, supportive community where employees feel they belong and can use their unique experiences, perspectives and skills to make a difference in the lives of others.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.

Responsibilities

• Project Management - work with department managers and other project stakeholders to manage projects of varying sizes and types, end to end
• Equipment / systems selection – develop and document equipment / system requirements, assess alternative solutions, and contribute to CAPEX / CPR preparation and submission
• Facilities and utilities management - design, modification, installation and commissioning.
• Equipment validation - develop validation / commissioning documentation, and be involved in the installation and qualification of new equipmen

Duties

• Development and management of Project Plans/Programs including schedule and cost reports for the overall management of projects and communication to relevant stakeholders.
• Liaise with department Managers, site SMEs, and external suppliers to ensure successful project scope and delivery to meet schedule and cost targets
• Contractor management and supervision
• Ensure projects meet site compliance requirements and processes including change control and validation to cGMP and Viatris standards
• Review technology and initiate innovative process and technology improvements
• Assist and support equipment / system owners with technical issues as required
• Communicate and endorse safety practices, ensure projects meet all site and safety standards and requirements e.g., JSA/SWMS Permits etc., monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives
• Carry out all other duties as directed by managemen