AUS_Technical Operations Associate

Posted 5 Days Ago
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Boorabbin, Western Australia, AUS
In-Office
Entry level
Pharmaceutical
The Role
The Technical Operations Associate ensures operational excellence by verifying reports, conducting IPC checks, managing CI projects, and updating quality documentation.
Summary Generated by Built In

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.

   

Overview:

The Technical Operations Associate’s main responsibility is to ensure that operational excellence and efficiency is achieved, and improvements are made to standards as a primary measure of success. In addition, the person will work closely with Production and other key Departments on CI projects ensuring new/updating existing equipment and/or processes are implemented and trained out successfully.

Primary Responsibilities:

  •  Verify ERP generated reports against the production activity stock issuance and accountability through reconciliation.

  • Perform In-Process Control (IPC) checks and verification that the correct procedures are being followed, and all associated documentation has been completed correctly, focusing on right first-time approach

  • Action and be responsible for independent approval signatory for production actions in line with PCI procedures

  • Active involvement in Continuous Improvement (CI) Projects, including improving existing processes and the introduction of new processes and equipment

  • Conduct On-the-Job Training and/or Assessment for updated or new Processes and equipment

  • Manage Action items from CAPA’s and Change controls effectively and in timely manner

  • Participate in and contribute to risk assessments for equipment, processes and safety as required.

  • Update process steps in Master Batch Records (Packaging) templates as per Change controls

  • Review MBR processing steps and align with packaging and labelling activity

  • Generate quality documentation such as, updating existing or creating new procedures and work instructions, to assist with the introduction of new or updated processes and equipment

  • Any other tasks/ projects as required by your manager.

Qualifications & Experience:

  • Experience in the manufacturing and/or packaging in the Pharmaceutical Industry

  • Bachelor of Science, Pharmacuetical, Engineering or equivalent qualification

  • Excellent English written and verbal skills with strong attention to detail

  • Strong organizational skills, the ability to multi-task and manage competing priorities efficiently

  • Computer proficiency in IT systems such as;  ERP, MS Office suite of Products (Word, Excel etc.), database management and the ability to navigate the internet.

  • Working knowledge of PIC/s Good Manufacturing Practices (GMP)

  • Working knowledge of PIC/s Quality Management System, especially change management

Key Behavioral Competencies:

  • Strong written/oral and mathematical skills.

  • Strong organizational skills, the ability to multi-task and manage competing priorities.

  • Ability to work independently and deal with sensitive and confidential matters.

  • Ability to be a team-player and work within a cross-functional team environment.

  • High level of professionalism, ethics, communication and responsiveness 

  • Accountable for quality of work

  • Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values

  • Collaborative, team player

  • Excellent interpersonal, written and verbal communication

  • Self-motivated and achievement orientated

  • Trusting and trustworthy

  • Conscientious and diligent

  • Positive, embraces and responsive to change

  • Displays Excellent Time management

  • Ability to display original thinking and creativity

  • Ability to demonstrate attention to detail

  • Ability to exhibit sound and accurate judgment

Reporting:

The role reports to the Technical Operations Associate Manager, and will work closely with Production, Project Management, Facilities and Engineering, and Quality.

#LI-AK2

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Skills Required

  • Experience in the manufacturing and/or packaging in the Pharmaceutical Industry
  • Bachelor of Science, Pharmaceutical, Engineering or equivalent qualification
  • Excellent English written and verbal skills with strong attention to detail
  • Strong organizational skills, the ability to multi-task and manage competing priorities efficiently
  • Computer proficiency in IT systems such as ERP, MS Office suite of Products, database management
  • Working knowledge of PIC/s Good Manufacturing Practices (GMP)
  • Working knowledge of PIC/s Quality Management System

PCI Pharma Services Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.

  • Retirement Support Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
  • Leave & Time Off Breadth PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
  • Affordable Benefits Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.

PCI Pharma Services Insights

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The Company
HQ: Philadelphia, PA
2,259 Employees

What We Do

PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.

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