Supports commissioning, qualification, and validation of pharmaceutical fill-finish facilities, utilities, and equipment in GMP manufacturing environments. Responsibilities include controlled documentation, equipment qualification, risk analyses, design reviews, FAT/SAT, IQ/OQ/PQ execution, filling-line integration, MES recipe startup and debugging, project tracking, and stakeholder coordination. The role requires hands-on cleanroom experience with vial filling and aseptic processing systems, plus strong technical writing and project management skills.
POSITION SUMMARY:
We are looking for a CQV/Fill Finish Engineer to join our team on a 12-month contract. The CQV/Fill Finish Engineer will play an essential role in supporting the CQV activities and fill finish processes in a GMP manufacturing environment. This position requires a strong understanding of CQV and fill & finish processes and the ability to collaborate effectively with project teams. The ideal candidate will be responsible for assisting in the creation of key documentation, ensuring project milestones are tracked, and providing hands-on support in cleanroom environments.
DUTIES AND RESPONSIBILITIES:
- Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
- Assists in authors, revises, reviews, and completes controlled documents for CQV projects.
- Assists to review and qualify equipment for commissioning, qualification, and validation activities.
- Supports to write and review GMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Assist to initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
- Ensure system integration with filling lines and compliance with validation requirements.
- Support MES recipe startup, debugging, and documentation updates to align with process optimization efforts.
- Collaborate with client teams, vendors, contractors, and cross-functional stakeholders to deliver project objectives.
- Manage project activities, timelines, and status reporting while ensuring compliance with cGMP and data integrity requirements.
DEMONSTRATED COMPETENCIES:
- Business
Development - Identify and
target potential clients. Work in a team environment; develop and execute a
plan, in alignment with company vision, mission and strategic plans to engage
potential customers.
- Relationship Building –
Works with and across formal and informal professional and social networks to
build long-term partnerships and connections in the life science industry and
Internal team.
- Negotiation Skills –
Active listening, needs assessment, and presents visions to build a consensus.
- Analytical Skills –
Identifies, researches, and demonstrates logical reasoning to communicate
critical information.
- Rational Persuasion –
Presents key factors, influencing factors, and strategic goals to assist
stakeholders in identifying solutions.
- Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication
can/does affect people and their outcomes.
- Agility – Meets objectives by responding
to competing and changing priorities and multiple tasks under inflexible
timelines.
Requirements
REQUIRED EDUCATION AND WORK EXPERIENCE:
- Bachelor's Degree in Engineering or Life Sciences.
- Minimum 3 years of CQV and Fill Finish experience within GMP-regulated environments.
- Hands-on experience with vial filling equipment and processes.
- Strong understanding of cGMP requirements, data integrity, and validation lifecycle principles.
- Excellent technical writing, communication, project management, and stakeholder engagement skills.
- Exposure to ancillary Fill Finish systems including isolators, depyrogenation tunnels, sterile filtration systems, and related aseptic processing equipment.
- Ability to manage multiple project priorities while working directly with client and site teams.
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What you need to know about the Melbourne Tech Scene
Home to 650 biotech companies, 10 major research institutes and nine universities, Melbourne is among one of the top cities for biotech. In fact, some of the greatest medical advancements were conceptualized and developed here, including Symex Lab's "lab-on-a-chip" solution that monitors hormones to predict ovulation for conception, and Denteric's vaccine for periodontal gum disease. Yet, the thousands of people working in the city's healthtech sector are just getting started, to say nothing of the tech advancements across all other sectors.
