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PSC Biotech® Corporation
POSITION SUMMARY: The Project Engineer is responsible for delivering capital engineering projects across the full project lifecycle, from design and scoping through procurement, installation, commissioning, and qualif…
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About the role
POSITION SUMMARY:
The Project Engineer is responsible for delivering capital engineering projects across the full project lifecycle, from design and scoping through procurement, installation, commissioning, and qualification. The role ensures projects are delivered safely, on time, within budget, and in compliance with applicable GMP and regulatory standards.
DUTIES AND RESPONSIBILITIES:
Lead and deliver capital engineering projects from concept through to completion
Manage project scope, schedules, and budgets to ensure successful outcomes
Coordinate equipment installation, commissioning, and qualification activities
Monitor project progress and provide clear, regular updates to key stakeholders
Support equipment procurement and manage vendor and contractor engagement
Review quotations and cost estimates, contributing to value engineering initiatives
Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as required
Oversee onsite installation and commissioning activities at client or project sites
Support equipment qualification activities, including IQ, OQ, and PQ
Prepare and maintain project and qualification documentation in line with regulatory standards
Ensure all project activities and documentation comply with GMP, TGA, FDA, and GxP requirements
Partner closely with Quality and Validation teams throughout the project lifecycle
Support audits, inspections, and regulatory interactions as required
Work collaboratively with internal teams and external vendors to deliver project outcomes
Coordinate across engineering, quality, procurement, and operations functions
Maintain clear, professional communication with all project stakeholders
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 (Chemical, Mechanical, Electrical, or related discipline)
3+ Years experience delivering engineering projects in a regulated environment
Understanding of GMP and regulated industry requirements
Experience supporting equipment installation, commissioning, and qualification activities
Background in pharmaceutical, biotech, medical device, or similar regulated industries (preferred)
Strong organisational, communication, and stakeholder coordination skills
Ability to manage multiple tasks and priorities effectively
Exposure to project management and validation practices is desirable
sign in above to apply · via biotech.zohorecruit.com
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