What are the responsibilities and job description for the Facilities Engineering Associate position at Imvax, Inc.?
Imvax™ is a clinical-stage biotechnology company focused on the development of novel patient-specific immunotherapy strategies for the treatment of malignant gliomas and other cancers with unmet medical needs. It was launched as a stand-alone company in December 2015, to accelerate research and development of its glioblastoma treatment and opened a state-of-the-art headquarters and research facility in Philadelphia in early 2020. The company is accelerating the development of IGV-001 and expects to initiate a Phase II trial in 2022 and is conducting pre-clinical studies across a variety of other solid tumors with the aim of submitting additional INDs in 2022.
IGV-001 is a first-in-class autologous cell therapy in development for the treatment of newly diagnosed glioblastoma multiforme (GBM). Based on early clinical research, one treatment with IGV-001 has the potential to trigger a multi-pronged immune response, including a short-term innate immune response followed by longer-term powerful adaptive immune activity that is selectively directed at tumor cells. A combination product, IGV-001 has been granted orphan drug designation by the FDA.
IGV-001 is a first-in-class autologous cell therapy in development for the treatment of newly diagnosed glioblastoma multiforme (GBM). Based on early clinical research, one treatment with IGV-001 has the potential to trigger a multi-pronged immune response, including a short-term innate immune response followed by longer-term powerful adaptive immune activity that is selectively directed at tumor cells. A combination product, IGV-001 has been granted orphan drug designation by the FDA.
Position Overview
We are seeking a talented and highly motivated Facilities Engineering Associate to work with our Facilities, Manufacturing, Process Development, and R&D teams to provide hands-on Calibration and Metrology support, equipment management services and validation support. The successful candidate will schedule and perform maintenance of equipment utilized by R&D and GMP end-users, in conjunction with third party resources. The successful candidate will support the Facilities Department complying with cGMP, SOPs and applying GDP (Good Documentation Practices). This individual will oversee ensure that contractors are trained on our SOPs and complete the tasks in a compliant manner, ensuring that the necessary documentation is completed accurately. This is a full-time position reporting to the Facilities Management Lead.
Key Responsibilities
- Complete calibrations and maintenance activities with accurate and timely GMP documentation following Company SOPs
- Develop, implement, and deploy validation policies, procedures, and protocols. Work alongside technical functions including Manufacturing and Quality to create and execute validation protocols, and equipment, systems and process validation studies
- Read quality control manuals and testing specifications to obtain data to test and / or calibrate specific devices
- Ensure validation follows a lifecycle approach from URS development through equipment/facility retirement. Ensure the validated state of equipment, systems, and processes are maintained through periodic review and revalidation programs
- Support the maintenance of all facilities working standards (manufacturing, utilities, and labs)
- Use of hand tools and precision measuring and calibrating instruments and equipment
- Interact with other departments and personnel to resolve any calibration or equipment issues
- Provide guidance and recommendations on selection of instruments and operational parameters
- Maintain a safe work environment; work in a safe manner following all safety SOPs and wear Personal Protective Equipment as required
- Obtain and sustain gown qualification for the cleanroom areas
- Maintain accurate record keeping of equipment and systems while being cGMP compliant
- Work independently and make sound judgments regarding work methods and tools
- Work with third party Vendors while performing services on the equipment to ensure that all are following Company and GMP policies
- Review, investigate, and report on the identification of Out of Tolerance (OOT) conditions. Assist with investigations and corrective actions to preclude the recurrence of similar issues
- Keep inventory of equipment critical spare parts
- Support investigations, change controls, RCAs, or new projects
- Execute and/or ensure that assigned Calibrations and Work Orders (WO) are completed per schedule
- Maintain equipment lists and enroll new equipment into calibration and maintenance schedules; Generate weekly and monthly system reports
Professional Requirements
- A minimum of 7 years of equipment maintenance and calibration/metrology related experience in the biotech or pharmaceutical industry
- Bachelor’s degree preferred
- Must have an excellent understanding of GMP, lab operations, and a working knowledge of validation protocols: IQ, OQ, and PQ
- Mechanical knowledge of equipment and tools, including their designs, uses, repair, and maintenance such as Biosafety Cabinets, incubators, centrifuges, refrigerators, freezers, and other general laboratory equipment
- Broad knowledge of GMP principles, concepts, practices, and standards in the US and internationally
- Broad knowledge of 21CFR Part 210 and 211
- Specific calibration and metrology training preferred
- Ability to obtain and sustain gown qualification for the cleanroom areas
- Requires the use of basic math skills and the ability to use technical calibration equipment
- Ability to troubleshoot basic electrical, programmable logic controllers (PLC), plumbing systems and issues
- Proficient problem-solving abilities along with being detail oriented
- Ability to work and communicate cross-functionally
- Good written and verbal communication and interpersonal skills
- Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment
Attributes
- Ability to thrive in a fast-paced, entrepreneurial environment with busy, high-performing colleagues
- Ability to function at a high level in a team setting, adapting to changing environment as needed
- Positive management approach: ability to build strong relationships regardless of their background and expertise
- Strong leadership skills
- Recognized by former colleagues, customers, manager and/or direct reports for attributes congruent with Imvax values
- Excitement about the vision and mission of Imvax
Key Competencies
- Analytical Thinking: Ability to comprehend a situation by breaking it down into its components and identifying key or underlying complex issues. Systematically organizes and compares the various aspects of a problem or situation and determines cause-and-effect relationships and able to define and summarize actionable recommendations
- Patient Focused: Dedication to enabling translation of preclinical research into impactful human therapies
- Communication skills: Ability to understand the audience needs across all forms of communication (phone, in-person, email and documents) and to convey the information concisely and in an engaging manner
- Self-motivated: To initiate strategic independent and collaborative work assignment(s); raises hand to assist coworkers proactively
- Flexibility: Able to reprioritize as competing interests arise and to operate successfully in an environment with a developing structure
- Accountability: Strong commitment to ensure quality and timely deliverables while maintaining and building relationships with coworkers, managers, vendors, and clients
Our Values
- Collaboration: The working practice for a common purpose to achieve business purposed and benefit
- Innovation: A new method, idea, product, etc.
- Patient Centered: Respectful of, and responsive to, individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions
At Imvax we pride ourselves on being a patient centered, collaborative and innovative Clinical-stage Biotech company developing cancer immunotherapy treatment through our proprietary platform. With a brand-new purpose-built laboratory space located in the company’s headquarters at the Curtis Center in central Philadelphia, PA and a recently completed round of fundraising that resulting in an additional $112 million dollars, Imvax is poised for growth and is excited about the possibility of you joining our team. At Imvax, you will find an exciting scientific environment with industrial and academic partners, opportunity to present findings, as well as a competitive remuneration and incentive package.
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