Engineer Senior
Belcan
Job Title: Engineer Senior
Location: Thousand Oaks, CA
ZIP Code: 91320
Start Date: Right Away
Keywords: #DrugEngineer
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:
Sr Engineer will drive excellence and innovation in large molecule drug product manufacturing.
* Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
* Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
* Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
* Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
* Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
* Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
Preferred Qualifications
* Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
* 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
* Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
* Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilization would be an advantage.
* Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
* Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
* Strong knowledge of Drug Product Manufacturing
* Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
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
ZIP Code: 91320
Start Date: Right Away
Keywords: #DrugEngineer
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:
Sr Engineer will drive excellence and innovation in large molecule drug product manufacturing.
* Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
* Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
* Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
* Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
* Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
* Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
Preferred Qualifications
* Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
* 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
* Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
* Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilization would be an advantage.
* Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
* Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
* Strong knowledge of Drug Product Manufacturing
* Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
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
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