Job Information
Belcan Engineer Senior in Thousand Oaks, California
Engineer Senior
Job Number: 348502
Category: Manufacturing Engineering
Description: Job Title: Engineer Senior
Pay Rate: $48.71 / hr
Location: Thousand Oaks, CA
Area Code: 805, 820
ZIP Code: 91320
Start Date: Right Away
Keywords: #Engineering
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:
Hybrid - MUST BE LOCAL TO USTO
Monday, Wednesday, Friday (Remote)
Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am- 4pm
Job Summary
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.
RESPONSIBILITIES:
Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
Apply core engineering principles to develop physical test methods for medical device and combination product systems.
Perform data analysis to support method development, qualification, validation, and transfer
Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
Coordinate gauge and equipment development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly and performance requirements.
Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
Generate procedures necessary to support department and new product equipment.
Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
Excellent communication (written and verbal) and organizational skills
Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
Networks with manufacturing, quality and regulatory organizations both internal and external to Client
Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
Integrates partner/vendor timelines with Client timelines as appropriate
Basic Qualifications:
Doctorate Degree OR
Master's Degree and 3 years of Engineering experience
OR Bachelor's Degree and 5 years of Engineering experience
OR Associate's degree and 10 years of Engineering experience OR
High school diploma/GED and 12 years of Engineering experience.
Preferred Qualifications:
M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
Experience with managing technical teams, including setting priorities and leveling resources
Technical writing experience
Spanish language skills preferred
Experienced with SolidWorks (or other 3D-CAD software)
Familiar with equipment and software IOQ
Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
Experience with change controls, deviations, CAPA
Experience with combination products and device regulatory requirements
Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
Experience with machine controls (PLC, HMI) and vision systems
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):
Required Education: Not Specified
Benefits:
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