United States onlyA career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary:
Resilience is ushering in an era of “Biomanufacturing-as-a-Service” that we expect will displace in-house manufacturing as well as traditional contract development and manufacturing organizations (CDMOs). We see this as a paradigm shift in biomanufacturing akin to the IT industry’s adoption of Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) that rendered obsolete corporate-owned/operated data centers or corporate servers co-located in hosting facilities.
The Engineer IV, QC Systems is someone whose experience reflects curiosity in new technology, creative solution engineering, and interest in technical mentorship. This position is cross-functional in nature, with a focus on customer focused quality control systems support. The Digital Quality Control systems portfolio includes, but not limited to, Environmental Monitoring, Utility Monitoring, Empower and more with global and site specific instances. The Position will further specialize in Empower Enterprise but should expect to cross train to ultimately be able to support all systems at some level as required by customer/site demands. The Engineer IV, QC Systems will position to support Quality Control Laboratories, as well as other site customers such as the process execution teams and Aseptic Control Team. In addition to support of systems specifically mentioned above, support of future QC systems as identified / adopted by the business.
Position Responsibilities:
Participate as a key member of Digital QC system implementation projects, which may include requirements elicitation, technology evaluation, software configuration, customization, testing, validation, support, and end-user knowledge transfer.
Identify integration points with other systems (e.g., LIMS, LES, and Laboratory Equipment) and understand the technical architecture. Support data exchange activities with interfaced systems.
Define, implement, and promote mechanisms to ensure standardized implementation, operation, and maintenance of Digital QC Systems across all Resilience sites.
Participate in the development, implementation and maintenance of best practices, policies, standards, and procedures for Digital QC systems across the Resilience network.
Analyzing and designing new business processes along with identifying and defining detailed product requirements and use cases.
Document as-is and to-be states of QC processes; create and maintain detailed QC business maps, business requirements documents, and technical requirements documents.
Collaborate with Quality on initiatives and projects related to system implementation (e.g., integrations, data integrity and risk management).
Provides training and support to scientific staff in the use of automation systems.
Responsible for troubleshooting technical and validation issues that arise in the support of the support of Digital QC systems (EM/UM/Empower).
Minimum Qualifications:
Hands-on experience with the implementation of QC computerized systems (e.g., EM/UM/Empower) in the pharmaceutical or biotechnology industry is required.
Must possess strong knowledge of laboratory technology systems development life cycle, computer systems validation, application development or systems integration.
Knowledge of industry standards related to validated computerized systems and GAMP5.
Technology agnostic. Must possess the ability to adapt, learn and apply the correct technology at the right time.
Excellent oral and written communication skills with strong technical writing experience required.
Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.
Preferred Experience:
Knowledge of project/demand planning tools (e.g., Jira, Confluence, Smartsheet, etc.).
Knowledge of Environmental Monitoring and Utilities monitoring processes.
Knowledge of GxP processes and systems.
Specific knowledge of Novatek and/or MODA.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
