Senior Engineer, Quality Control Applications

Resilience is ushering in an era of “Biomanufacturing-as-a-Service” that we expect will displace in-house manufacturing as well as traditional contract manufacturing and development 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.

As a Senior Systems Engineer on the Quality Control Applications team in Digital Operations you will bring to realization the Resilience Laboratory Applications and Informatics strategy across the Quality network. As a an engineering leader you will drive harmonized deployment, and management of Quality Control (QC) applications across the Resilience network. You will lead and support across applications activities including gathering/defining user requirements, implementation, validated testing, training, maintenance, administration, support, and application integration. The preferred candidate will thrive in a dynamic, multidisciplinary environment and use their experience and creativity to support the mission of creating industry-defining biomanufacturing technologies that will improve access to the next generation of complex medicines.

This role requires strong technical , engineering and problem-solving skills, will need to have a good understanding of laboratory processes and instrumentation. Additionally, this role will work with vendor-based consultants and services to ensure continued operation of commercial off-the-shelf (COTS) systems and interfaces to other systems (e.g., ERP, MES, LMS, DMS, EAM).

Responsibilities

• Lead technical activities as a key member of Digital QC Application implementation projects, which may include requirements elicitation, technology evaluation, software configuration, customization, testing, validation, and end-user knowledge transfer.
• Identify integration points with other systems (e.g., ERP, MES, LMS, DMS, EAM 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 Applications across all Resilience QC laboratories.
• Participate in the development, implementation and maintenance of best practices, policies, standards, and procedures for Digital QC Application across the Resilience network.
• 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 Digital Quality on initiatives and projects related to QC Applications (e.g., change management, data process mapping, Computer Systems Validation (CSV), data integrity and risk management).
• Provides training and support to scientific staff in the use of QC Applications and Integrations.
• Responsible for application administration, troubleshooting technical and validation issues that arise in the support of the support of Digital QC Applications (e.g., LIMS, LES, EM, CDS, SDMS).

Qualifications

• 5+ years of hands-on experience implementing QC systems (e.g., LIMS, LES, CDS, EM, SDMS) in the pharmaceutical or biotechnology industry.
• 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 Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5.
• Technology agnostic. Must possess the ability to adapt, learn and apply the correct technology at the right time and not be biased towards an underlying platform or technology. (e.g., Java only).
• 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

• Strong technical aptitude and the ability to learn new processes and systems rapidly.
• Knowledge of project/demand planning tools (e.g., Jira, Confluence, Smartsheet, etc.)
• Knowledge of GxP processes and systems.
• Knowledge of biopharmaceutical production.
• Knowledge of SQL, Java, Python, or any programming experience.

• Familiarity with the Cloud preferably AWS and key approaches to security and change management/deployment.