Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology, and have the potential to transform therapeutic categories.
We focus our efforts on serious diseases that are prevalent and poorly controlled. Our most advanced investigational product is ITCA 650 in type 2 diabetes (T2D). Currently in phase 3 development, this matchstick-sized titanium mini-pump is placed under the skin where it delivers exenatide continuously and consistently over 12 months. As such, this product fundamentally changes how therapy gets delivered by the healthcare system to patients, as well as how it is distributed and reimbursed. Our disruptive new approach holds significant promise as a 'game-changing' treatment in this increasingly common and important disease, and will require a new level of thinking and acting.
We Are Growing
Since the 2012 round of financing, much forward progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facilities, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise both on our Board of Directors as well as on our Leadership Team through newly acquired members who bring vital new capabilities with them.
A key element of pride during our progress has been our ability to remain fully independent through our rounds of financing so that we continue to have full strategic and executional control over our large global phase 3 clinical trial program, and all aspects of our rapidly evolving business plan. While we are obviously accountable to our stakeholders for progress, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of our Engineering team, the Senior Engineer/ Principal Engineer, Validation, is responsible for supporting commissioning, qualification and validation (CQV) activities relating to manufacturing process, cleaning process, production equipment and utility systems. These will encompass new facility/equipment, process/equipment changes, and periodic review/requalification/revalidation. The incumbent prepares validation plans, protocols, test scripts and reports throughout all stages of validation from initiation to continuous monitoring. Furthermore, the incumbent will be responsible for coordination and execution of validation activities.
Duties and Responsibilities:
Perform cleaning validation and qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification).
As needed manage and provide directions to contract personnel performing cleaning validation and facility/equipment/utility qualification.
Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
Support the development of validation master plans, validation plans, SOPs, risk assessments, user requirements, and validation protocols for new facility/equipment/utility, and process/equipment modifications.
Support validation periodic reviews, requalification, and revalidation.
As needed prepare and update validation policies, master plans, and SOPs.
Work independently and directly interface with personnel from multiple departments including Product development, Project Management, Manufacturing, Engineering, Facilities, and QA/QC.
Support corrective actions including investigating and resolving deviations related to validation.
Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.
Expertise in the following areas are must: Facility/Equipment/Utility Qualification, Cleaning Validation, and CIP/SIP qualification.
Familiar with both domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210 and 211, EU Annex 1, Annex 11, and Annex 15).
Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Aseptic Processing guidance, FDA Process Validation guidance, PIC/S guidance documents, ICH Quality Guidelines, ISPE guidance, ASTM E2500, and PDA Technical Reports).
Experience with regulatory inspection.
Strong understanding of quality risk management principles, including best practice in risk based C&Q approach.
Hands on experience in generating user requirements and conducting system and process risk assessments, including FMEA generation.
Project Management experience is a plus
Demonstrated knowledge of manufacturing of sterile pharmaceutical products and/or drug/device combination product manufacturin
Must demonstrate the ability to think critically and analytically with acumen for trouble-shooting and problem solving.
Good interpersonal skills, and accountable with excellent verbal and written communication
Ability to function effectively and independently in a fast-paced, dynamic
Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.
Read and interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&I
Expert Microsoft Word / Powerpoint and Intermediate Microsoft Excel skills are required.
Strong team player aligned with lntarcia Corporate
For Senior Engineer, 6+ years of validation experience in Pharmaceuticals or relevant regulated industry. For Principal Engineer, 10+ years of validation experience in Pharmaceuticals or relevant regulated Industry.
GMP manufacturing experience in sterile pharmaceuticals is
Experience with drug/device combination product is a plus.
Aseptic processing experience is a
Hands on facility/equipment/utility qualification and cleaning validation experience in GMP environment is required.
Sterilization (steam sterilization / dry heat depyrogenation / gamma irradiation) and process validation experience is a plus.
Hands on experience with CIP/SIP qualification is required.
Automation and Part 11 validation experience is a plus.