Job Title: Engineer Mechanical Biopharma (JP9751 Location: Thousand Oaks CA. Employment Type: Contract Business Unit: Commercial Platforms Methods and Automation Duration: 18 months (with likely extensions and/or conversion to permanent) Posting Date: 1/31/2022 Notes:
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: Ideal candidate MS in mechanical Engineering 12 years of professional work experience solid works technical writing skills Statistical skills great problem solving skills. This is an entry level role.
Job description The Engineer will work under the team: Mechanical Engineering Methods. They will be responsible for engineering activities required for the development qualification validation and transfer of Physical GMP Test Methods for combination products devices primary containers and secondary packaging components. The Engineer will have the ability to work on projects that may involve changes or new product processes tooling or equipment introduction to improve quality reliability and reduce cost. Phases of projects include: developing combination product test methods providing key expert support for qualification validation transfer and life cycle support of methods for manufacturing new product introduction training and production support.
Why is the Position Open Backfill.
Top Must Have Skills:
Solid works program / CA software very preferred.
Technical writing and project management experience a must.
Validation/ equipment validation a plus.
Experiment completion.
Must be able to complete technical reports and writing.
Day to Day Responsibilities:
Develop qualify and validate GMP physical test methods for vials prefilled syringes and injection devices.
Provide support of senior staff for investigations as well as new process development required to improve manufacturing operations.
Coordinate test method development and delivery with selected contractors and vendors.
Ensure that qualification parameters are met for product requirements.
Generate procedures necessary to support department and new process equipment.
Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
Participate in and assume responsibilities of team functions as assigned i.e. subject matter experts for test equipment
Generate/author and own the Test Method documents: Procedures engineering drawings specifications protocols reports etc.
Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
Perform other duties as required by the Group Manager
Comply with the requirements responsibilities and authority as required
Communicate and collaborate internally to ensure alignment commitment to project objectives and timelines as well as to ensure effective of projects
Network with manufacturing quality and regulatory organizations both internal and external to client
Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
Basic Qualifications: Masters Degree Or Bachelors Degree and 2 years of engineering/scientific experience (internships are considered)
Employee Value Proposition: Career growth and opportunity.
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.