Pfizer Senior Validation Associate in Mulgrave, Australia

Pfizer Melbourne is currently looking for an enthusiastic and motivated candidate to work as a Senior Validation Associate based in Melbourne Victoria.

As a Senior Validation Associate you will execute site validation projects for all site Facilities, Equipment and Services. The role is responsible for ensuring new equipment and facilities are qualified in a timely and compliant manner.

Role Responsibilities:

The Senior Validation Associate is responsible for prospective qualification of site equipment, facilities and services associated with new capital projects. The incumbent will:

  • Execute and Deliver site critical validation projects in a timely, compliant and cost effective manner

  • Provide leadership and support to junior associates to ensure the effective and efficient delivery of Equipment Validation projects.

  • Conduct Master Planning Services for Validation projects.

  • Ensure efficient and effective practices are in place to provide valued service to internal and external customers.

  • Management of plant database to ensure all facilities, equipment and services is appropriately registered and qualified per internal procedures to meet business needs and agreed targets.

  • Present all facets of Equipment Validation during Regulatory, Customer and Internal audits.

  • To provide progress updates for selected Key Performance Indicators to the Site Quality Council.

  • Develop, introduce and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards

  • Inform management and/or Quality on issues that may affect batch disposition.

  • Ensure KPIs for the Equipment Validation group are monitored and reported as agreed.

The Ideal Candidate

You will be flexible, self-motivated and have a 'can do' attitude. The successful candidate should ideally have proven experience of working in a similar role or in a cGMP flexible manufacturing environment, with excellent communication and writing skills. Prior experience with medical devices, biologics and powder filling is beneficial. The role will be challenging and require someone dynamic with the ability to work on multiple projects. You will be used to meeting challenging deadlines and improve performance through continuous improvement and use of business tools.

Your IT skills will be of a high standard particularly in Excel and Project Planning tools such a MS Project.

Qualifications /Knowledge

  • Degree level qualification preferably in Engineering/ Science

  • Proficiency in Word/ Excel / Outlook / Project (or equivalent)

  • Excellent English both written and oral.

  • Effective communication and negotiation skills

  • Validation experience in a similar field: 8 - 10 years

  • Strong analytical and problem solving skills.

  • Quality and detail focus

  • Good communication skills, proactive, good initiative and ability to work under pressure.

  • Independent worker being able to work with minimal supervision.

  • High level of self-motivation.

  • Able to learn new techniques and procedures.

  • Well Organized and Effective Planner

Other Requirements

  • Must be eligible to work in Australia

If interested then apply now.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.