Device Engineer

New Yesterday

Job Description

Target PR Range: 30-40/hr
*Depending on experience

Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.
The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
This may include, but is not limited to, the following:
•Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
•Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
•Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
•Developing, enhancing, automating, and managing test data
•Network with manufacturing and quality organizations internal
•Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
•Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills
•Experience working in a regulated industry, exposure to GMPs
•Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
•Statistical analysis, and knowledge of Gage R&R,
•Knowledge of Optical measurement devices, force testers, BLE testing
•Test method development, CAD design, Solidworks, mechanical modeling
•Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:
•Passion for proactively identifying opportunities through creative data analysis and modeling
•Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
•Ability to manage multiple, competing priorities simultaneously, experience with MS Project, Smartsheet

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Apply
Location:
Newbury Park

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