What are the responsibilities and job description for the Process Development Engineer position at Pharmavise Corporation?
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com
We are actively seeking skilled and knowledgeable professionals to join our team as Engineer – R&D Engineer II that can develop processes from start to finish, has practical aptitude in fixture design, test method validations, process characterization and process validation including operator instructions. This is a possible temp to hire. Below, you'll find a comprehensive job description detailing the responsibilities, qualifications, and expectations for this role:
Key Responsibilities
1. Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
2. Works independently to plan and schedule own activities necessary to meet timelines.
3. Designs and coordinates standard engineering tests and experiments.
4. Designs, procures, and fabricates tooling and fixtures.
5. Performs troubleshooting on new products/process problems as related to design, material, or process.
6. Summarizes, analyzes, and draws conclusions from test results.
7. Prepares standard reports/documentation to communicate results to technical community.
8. Responsible for engineering documentation.
9. Invents/ creates concepts and designs for new products/processes and submits idea disclosures.
10. May train and/or provide work direction to technicians.
11. Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
12. Demonstrates PDP/TPD system knowledge through delivery of high-quality deliverables.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
2 - 4 Years with BS degree. Mechanical Engineering degree is highly preferred.
Must have a BS engineering degree.
Methodology, design experience. Comfortable creating a process from scratch.
This is a challenging and rewarding opportunity for individuals passionate about ensuring the safety, efficacy, and quality of medical devices. Competitive compensation and benefits packages are available.
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com.
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
