Engineer II/Engineer III/ Senior Engineer (Sterility Assurance) - Hayward, CA | Biospace
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Engineer II/Engineer III/ Senior Engineer (Sterility Assurance)

Intarcia Therapeutics, Inc.

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Location:
Hayward, CA
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Development, Engineering, Manufacturing,

Job Description


Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.

At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.

Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System™, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.

We Are Growing

Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.

A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.

Supervised by the Director, Sterility Assurance Engineering, the Sterility Assurance Engineer will provide development and engineering support for GMP manufacturing operations related to the off-site gamma radiation, Ethylene Oxide (EO) gas sterilization of product parts and equipment, and in-house methods of sterilization, such as steam and depyrogenation. The Engineer will prepare sterilization protocols, procedures, technical reports and final reports. He/She will also perform sterilization validation, and maintain performance of dose audits and other sterilization requalification for documentation of continued sterility assurance to meet regulatory requirements. The Engineer assists the Director, Sterility Assurance Engineering in the design and evaluation of new sterilization options for products, parts and equipment. The Engineer coordinates activities between manufacturing, materials management, sterilization vendors and contract laboratories to meet sterility assurance criteria, regulatory requirements and Company policies, procedures and goals.

As a key member of the Engineering team, the Sterility Assurance Engineer will provide development and engineering support for GMP manufacturing operations related to the off-site gamma radiation, Ethylene Oxide (EO) gas sterilization of product parts and equipment, and in-house methods of sterilization, such as steam and depyrogenation.  The Engineer will prepare sterilization protocols, procedures, technical reports and final reports.  He/She will also perform sterilization validation, and maintain performance of dose audits and other sterilization re-qualification for documentation of continued sterility assurance to meet regulatory requirements.  The Engineer assists the Director, Sterility Assurance Engineering in the design and evaluation of new sterilization options for products, parts and equipment.  The Engineer coordinates activities between manufacturing, materials management, sterilization vendors and contract laboratories to meet sterility assurance criteria, regulatory requirements and Company policies, procedures and goals.

•   Organization of sterilization validations (planning, risk assessment, scope definition).
•   Validation protocol and report writing, and sterilization validation package completion to support regulatory submissions/approval.
•   Contribute to the continued maintenance of the validated state of sterilization, such as the writing of Standard Operating Procedures (SOPs) for performance of periodic Verification Dose Audits, and other sterility assurance documentation.
•   Coordinate management of sterilization load configuration specifications and provide validation when changes require it.
•   Work on validation activities for steam sterilization and depyrogenation in conjunction with the Validation department.
•   Coordinate availability of product or equipment samples for microbial testing, dose mapping, dose audits, and sterilization cycle exposures with manufacturing.
•   Assist with other related activities as requested by Intarcia.
•   The practice of good communication and coordination skills with Manufacturing, Materials Supply, contract test labs, and contract sterilizers is a priority.

Requirements


Qualifications:

•   A BS or BA degree in Engineering, or equivalent field.
•   Level Catagories:
1.   Engineer II: 2+ years of experience
2.   Engineer III: 5+ years of experience
•   Senior Engineer: 8+ years of experience
•   Fluency with cGMP manufacturing and regulatory regulations and sterile requirements for pharmaceuticals and devices.
•   Working knowledge of scientific and engineering principles (analytical methods).
•   Familiarity with microbiology and bioburden calculations a plus.
•   Minimal travel may be required (up to 10-15%).

•   Demonstrated knowledge of pharmaceutical manufacturing of sterile products, aseptic processing, medical device manufacturing, and process development.
•   Must demonstrate the ability to think critically and analytically and demonstrate troubleshooting and problem solving skills.
•   Good interpersonal, follow up, and excellent verbal and written communication skills.
•   Ability to function efficiently and independently in a fast-paced, changing environment.
•   Self-motivated and willing to accept temporary responsibilities outside of initial job description.
•   Well-developed skills with Microsoft Office.
•   Be willing to perform hands-on tasks to expedite the required activities.
•   Strong team player aligned with Intarcia Corporate Values.

•   Experience with gamma sterilization validation is preferred.  Experience with other forms of sterilization a plus.
•   Familiarity with pharmaceutical/medical device GMP manufacturing is a must.
•   Aseptic processing experience is a plus.
•   Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is required; process validation experience is a plus.
•   Familiarity with the following Standards and Guidance is preferred.
•   ISO 11137-1, ISO 11137-2, and ISO 11137-3
•   PDA Technical Reports/Guidances
•   EU GMP Annex 1, and US FDA Aseptic Processing Guidance
•   FDA Process Validation Guidance