Opportunities for Utilities, Facility, Equipment and Automation Validation for new filling line.
Construction of a new Facility is ongoing.
Equipment FAT is in final stages as the site prepares for SAT.
The filling line will use isolator technology with VHP.
There are exciting opportunities. We are currently seeking enthusiastic Validation Engineers ( 2 years fixed term ) with experience in:
- Facility Commissioning and Qualification/Validation
- Utility Qualification/Validation
- Equipment commissioning and Qualification/Validation
- Validation of Automated systems/CSV.
Please highlight in cover letter where your skills are most relevant.
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective Engineering team. You will be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your
problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for qualification and validation documents and reports related to equipment, products and processes.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team and to drive improvements. Your focus and ability to meet team targets will help in completing critical deliverables. You will be expected to lead end to end execution of qualification of equipment and systems. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Provide high level data analysis support for Investigations and drive quality decisions.
- Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
- Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.
- Manage routine Quality systems, such as Change Control, Document routing systems and and Investigations.
- Coordinate and communicate all testing with affected functional groups and evaluate test results.
- Maintain Site Validation Master Plan Support regulatory audits through the preparation, defense and interaction with auditors in areas related to equipment, instrumentation, facilities and utilities.
- Provide expertise for trouble-shooting and resolution of issues related to equipment, instrumentation, facilities and utilities.
- Assess potential impact of changes to qualified systems Identify and implement validation best practices to continuously improve the site validation program Represent engineering validation on site or network teams as necessary.
- Support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility.
- Support product transfers/new product development, regulatory queries, cost improvement projects or Drug Product plant support.
- Ensure integration of validation and requalification schedule in production schedule for implementation of validation activities and conduct validation deviations, participate in deviation investigations to identify root causes and define corrective and/or preventative actions. Support the unit where needed to assure due dates and customer needs are met.
Qualifications
Must-Have
- Bachelor's Degree
- 3+ years' experience
- Experience in Qualification of equipment used for sterile filling
- Experience in Detailed Design review, URS development and qualification protocols generation for initial qualification of a new filling line
- Experience in {Current} Good Manufacturing Practices {part of GxP}
- Strong working knowledge of a variety of quality systems and processes
- Familiarity with information systems, such as Global Document Management System, System Application & Products and Quality Tracking System
- Ability to work in a team environment and manage projects independently
- Strong ability to drive projects ensuring -accountability for required tasks
- Strong planning and communication skills
Nice-to-Have
- Master's degree
- Relevant pharmaceutical experience.
- Experience in lyophilisation or strong interest and motivation to acquire the skills
- Experience with Siemens PCS7
- Experience with integration of automated systems with multiple equipment
- Design and validation of automated batch records
- Experience with IMA filling equipment
- Experience with isolator filling and VHP
- Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices
Work Location Assignment: On Premise
At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:
Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options
*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
Quality Assurance and Control
#LI-PFE
