Job Title:Engineer Biotech Hybrid (JP10789 Location: Thousand Oaks CA. (hybrid) Employment Type: Contract Business Unit: Commercial Drug Product Duration: 1 years (with likely extensions and/or conversion to permanent) Posting Date: 09/12/22 Notes: Only qualified candidates need apply.
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: This process development engineer will support the commercialization and the life cycle management of drug products. The engineer will support the planning design implementation and documentation of process development laboratory studies related to drug product manufacturing.
This person will provide support to clinical and commercial fill / finish manufacturing operations. The engineer will participate on global multifunctional teams working in a highly matrixed team environment.
Responsibilities include authoring reviewing approving data verifying technical protocols reports product impact assessments risk assessments regulatory submissions and regulatory response to questions. On site laboratory work will be required. Execute process development scale experiments related to manufacturing unit operations and analyzes product quality data.
Top Must Have Skills:
Relevant STEM degree (e.g. Chemical Engineering Biomedical Engineering Biochemical Engineering chemistry pharmaceutical sciences or other) science background
Experience with technical writing and communication
Prefer 12 years of experience at least w/bio tech background
Day to Day Responsibilities: First year will require lab work in addition to computer work. Lab work will come in waves at time requiring the full work week on site. Averaged over a year the majority of work will be on computer.
scaled down drug product manufacturing process characterization studies (freeze thaw mixing formulation filling filterability product quality assays etc.
data verification
technical writing of protocols reports technical assessments
support regulatory writing marketing applications response to questions
create and deliver progress reports and presentations
Red Flags:
No science degree/background
Moving jobs frequently (e.g. risk they wont complete 1 year of work)
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.