PSC Biotech® Corporation

Project Engineer Melbourne

PSC Biotech® Corporation  •  Melbourne, AU (Onsite)  •  23 hours ago
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Job Description


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:


  • Support

    and deliver capital engineering projects from concept

    through

    completion.

  • Support delivery of

    project scope, schedules, and budgets to ensure successful outcomes

  • 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,

  • Assist

    with project scope, budget, schedule, and risk management.

  • Coordinate engineering design, construction, commissionin

    g, and validation activities.

  • Prepare technical specifications, project documentation, and procurement requirements.

  • Ensure projects are delivered safely, compliantly, on time, and within budget.

  • Support audits, inspections, and regulatory interactions as required

  • 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


REQUIREMENTS:


  • Bachelor Degree in Engineering or Science.

  • Minimum 3 years’ experience

    in
    commission,

    qualify

    and validating facilities

    or capital projects within a GMP/

    GxP

    -regulated environment.

  • Knowledge of project management principles, commissioning, qualification, and engineering systems.

  • Experience with risk-based CQV

    approaches.

  • Experience with packing line.

  • Hands-on experience executing and

    facilitating

    FAT, SAT, IQ, OQ, and PQ activities.

  • Understanding of

    quality systems, risk management, and contract administration.

  • Strong stakeholder management, communication, and problem-solving skills.
PSC Biotech® Corporation

About PSC Biotech® Corporation

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. PSC Biotech Corporation serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services.

PSC Biotech Corporation has three unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, and BioTechnique™.

Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.

To learn more, visit our website.

Industry
Biotech & Life Sciences
Company Size
501-1,000 employees
Headquarters
Pomona, CA
Year Founded
Unknown
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