PCI Pharma Services Maintenance and Validation Engineer in Moorabbin, Australia
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
This position will provide a variety of services to PCI Melbourne sites including Environmental Health and Safety and Facilities Management and Engineering support.
More specifically, overseeing equipment and facilities with a primary focus on engineering and maintenance. Responsibilities encompass aiding in the generation and execution of protocol(s), ensuring proper equipment upkeep, and effectively managing records utilizing BMRAM. The role will becoming a technical Subject Matter Expert (SME) in Sterile Fill Finish - Cytiva isolator filling technology as well as building utilities, encompassing HVAC and industrial gases. Additionally, the role will include managing contractor relationships to ensure efficient and effective project/maintenance execution.
Responsibilities & Duties :
Provide technical engineering support to GMP operations in a multi-product Sterile fill/finish and solid oral dose pharmaceutical manufacturing facility.
Ability to author production equipment and technical documents.
Partner with Production and Quality organizations in daily operations to maintain the equipment in a reliable state of control
Provides technical support and analysis for the resolution of deviations, investigations and equipment issues. Be an SME for various equipment. Complete technical investigations with regards to equipment and provide on the floor support. Identify, own and resolve equipment related issues proactively
Prepare Change Controls, CAPAs and Investigation reports related to the production equipment.
Initiate equipment Change Control process, prepares change control and validation history report of site equipment for audits Provide technical/equipment related investigations. Define relevant operational/technical standards and practices.
Provide URS for new equipment to be introduced.
Review and perform Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment
Execute validation protocols (IQ, OQ, PQ) with validation team and provide input where required.
Manage the safety of all Facility contractors onsite, including (but not limited to) inductions, permits, review of licences and issue of access cards.
Participation in PCI on call program to support out of hours emergencies and repairs.
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.
Qualifications & Experience:
Bachelor's Degree in mechanical engineering demonstrated experience in working in a technical pharmaceutical environment.
Statistical and Advanced Mathematical Skills
Experience with the installation and operation of complex and/or robotic manufacturing equipment.
Proficient in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Power, Point, CMMS, Building Management System.
Ability to work on multiple projects at the same time
Ability to meet aggressive timelines
Manufacturing and technical background and experience in pharmaceutical equipment, ensuring compliance with industry regulations and quality standards.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
Aseptic Filling or Robotic Pharmaceutical Manufacturing experience: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active pharmaceutical manufacturing operation.
Cleanroom/HVAC/Utility/Facilities Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and high understanding of heating, air conditioning, and refrigeration systems.
Computer Validation Focus: Ability to perform highly complex computer tasks and have experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11 and PCI guidelines.
Knowledge of EHS State and federal rules and regulations; knowledge of local policies and regulations
High level of professionalism, ethics, quality of work, communication and responsiveness at all times
Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision & Values
Analytical thinker and solution finder/problem solver
Collaborative team player who works well with others
Objective and robust decision maker
Self-confident and self-respectful
Excellent interpersonal, written and verbal communication
Self-motivated, achievement and outcomes orientated
Trusting and trustworthy
Conscientious and diligent
Positively embraces and is responsive to change
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
PCI Pharma Services
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