Mechanical Engineering Specialist - City Of Melbourne, Australia - Specialist Apps Pty LtdWe 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 ResponsibilitiesLead 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.RequirementsTechnician 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 QualificationsDegree 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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