process development Engineer
3 weeks ago
process development Engineer
Job Number: 351401
Category: Biomedical Engineering
Description: Job Title: process development Engineer
Location: Thousand Oaks, CA
ZIP Code: 91320
Start Date: Right Away
Keywords: #processdevelopmentEngineer
Benefits:
* Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.
* On the job training / cross-training to develop and expand skills, creating opportunity for advancement and personal development. Tuition reimbursement available for relevant development opportunities.
* Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.
* Scheduled performance reviews create opportunities for advancement and pay increases.
* We have many success stories from individuals who took advantage of the training, cross-training, and personal development opportunities for advancement. We also have success stories of individuals who desired a reliable, scheduled and consistent career with appropriate work-life balance, health benefits and good job security. Whichever way you define success, this work culture cares about team members and treats each individual with dignity, inclusion, respect and recognition.
* A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person. Our team has grown with referrals and internal promotions.
Responsibilities:
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple Client products to the aseptic fill finish manufacturing plants at Client Thousand Oaks and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liasing with various drug product teams to ensure successful technology transfer, with associated documentation, of Client products. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.
Responsibilities include, but are not limited to, the following:
* Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
* Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
* Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
* Support development and maintenance of technology transfer tools (clinical and commercial)
* Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
* Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
* Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
* Development of digital tools and models by leveraging data analytics and programming skills
* Support at scale characterization and/or process validation runs as person in plant
Preferred Qualifications:
* B.S. in engineering discipline with 1?3 years" experience or M.S. in engineering discipline with 0?2 years" experience
* Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
* Knowledge of and hands-on experience with various drug product technologies
* Displayed critical thinking, problem solving and independent research skills
* Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
* Excellent project management skills and ability to escalate relevant issues to project lead and line-management
* Strong cross functional team player with good communication skills (oral and written)
* Ability to work independently and as part of a team with internal and external partners
* Good computer and organizational skills with strong attention to detail
* Self-motivated with a positive attitude
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/D/V
Location: Thousand Oaks , CA
Minimum Experience (yrs): 1+
Required Education: Not Specified
Benefits:
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