Mechanical Engineering Specialist

6 days ago

Melbourne, Victoria, Australia Specialist Apps Pty Ltd Full time
About the Role

We are seeking a highly skilled Mechanical Engineering Specialist to join our team at Specialist Apps Pty Ltd. As a key member of our engineering team, you will be responsible for ensuring that our systems, facilities, and equipment meet the highest design requirements.

Key Responsibilities
  • Lead and simplify DQV functions, reports, and processes.
  • Support implementing safety programs for major capital projects.
  • Develop, qualify, and validate units, utilities, and/or equipment in assigned projects.
  • Initiate, author, revise, review, and complete controlled documents for DQV projects.
  • Review and qualify equipment for commissioning, qualification, and validation activities.
  • Write and review QA documents and technical specifications.
  • Collaborate with multiple departments on assigned project activities and deliverables.
  • Initiate and coordinate risk analyses, design reviews, execute FAT/SAT.
  • Contact and work with contractors and vendors on assigned projects.
  • Ability to travel as needed, domestic as well as internationally.
Requirements
  • Technician or Bachelor in Solution Engineering disciplines, Mechanical Engineering, Mechatronics or equivalent.
  • 7-10 years of applicable work experience in fabrication, manufacturing and experience with regulations.
  • 2-4 years of applicable work experience in a lab environment and R&D.
  • Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents, training and maintenance plans.
  • Proficient in developing SOPs, final reports and validation & quality policies.
  • Strong experience developing and executing DQV protocols.
  • Strong experience creating and maintaining DQV policies and processes.
  • Good understanding and compliance with c GMPs and CFR21 Part 11 guidelines (in the food and pharmaceuticals industry).
  • Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate data to actionable plans; demonstrated ability to develop and implement marketing and product/service strategies by converting them into tactical marketing plans; execute and deliver results.
  • Excellent presentation and communication skills, written and oral, for a variety of audiences.
  • Highly organized in planning and time management, with the ability to multi-task.
Preferred Qualifications
  • Degree in Mechanical or Electrical Engineering or equivalent.
  • 5-7 years relevant project or engineering experience.
  • 1-2 years' experience in GMP Manufacturing Facilities, experience in Lab / R&D projects, highly desirable.
  • Exceptional interpersonal skills to communicate effectively and build relationships with a broad spectrum of audiences at all organizational levels.
  • Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.
  • Native German language highly desirable plus knowledge of ISO, TGA, FDA and other regulatory standards, preferred.
  • Strong written and verbal communication skills; experience with Excel and MS Project.

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