Automation Data Analytics Engineer

• Monday-Friday 9:00am-5:00pm

• Act as a subject matter expert in data analytics, closely working with Manufacturing and Technical.
• Operations subject matter experts to define, prioritize, and document business needs and solution requirements; work with external and internal BI&T partners to develop data analytics and data science solutions, serving as the key conduit between business and BI&T.
• Create dashboards and visualizations using data analytics tools and conduct ad-hoc data analysis to support operational and business decision-making.
• Provide technical direction and expertise to Site teams (Manufacturing, Quality, Supply Chain, Shared Services, etc.) to support and improve capacity, quality, and cost, or to establish root cause.
• Work closely with end users and process owners to establish and maintain service level expectations across all functions and site systems.
• Support the Automation and Data Intake (assessment) and backlog of proposals and requests to utilize resources efficiently and ensure alignment with Site objectives, Network policies, practices, and Senior Leadership direction.
• Deliver key improvements across the manufacturing network by deploying recipe updates, manufacturing data analysis reports, and technical insight; provide MES product impact assessments to support investigations and product release.
• Contribute to the development and configuration of digital solutions - such as electronic batch records and process automation technologies - ensuring solutions are fit for intended use per business requirements throughout the full solution lifecycle.
• Support lifecycle management and project implementation at the site level, including participation in project teams to prepare schedules, execute technical projects, and develop presentations for stakeholders and management.
• Translate business requirements into functional and design specifications that are compliant, efficient, and effective.
• Champion change management initiatives and support process improvement programs; support consistent execution of automated system modifications and adherence to governing documents.
• Support Manufacturing Systems incidents, quality event investigations, and impact assessments on the process control strategy; contribute to process monitoring initiatives including data collection, end-to-end process analysis, and resolution of production issues.
• Lead the execution of QMS deliverables including creation and revision of SOPs, work practices, training materials, Change Controls, Change Actions, CAPAs, and technical reports; provide ownership of quality records for deviations and change actions related to shop floor activity.
• Support the Continued Process Verification (CPV) and process monitoring program, and participate in Technical Transfer efforts across the cell therapy network.
• Participate in and support Automated System lifecycle activities and improvements, including system and process reviews and business audits.
• Interface with Manufacturing, Quality, Supply Chain, MSAT, and other cross-functional teams; serve as applicable Manufacturing Automation System Business Owner and participate in routine plant operating meetings (i.e., Tiers, Townhalls, etc.).
• Continuously integrate with the business to understand current processes and provide technology guidance that enables and supports Digital Plant plans and strategies; stay current with industry trends and standards (e.g., PDA, ISPE).
• Adhere to and apply Global Regulatory and cGMP requirements; support health authority and internal inspections.
• Effectively collaborate across the organization at a global and local level to support business strategies, best practice operations, and Business Continuity (BCP).
• Provide coaching, mentoring, and guidance to team members to maximize effectiveness and cohesion; promote compliance with practices, policies, and procedures.

• Strong critical reasoning, decision-making, and strategic thinking skills with the ability to translate strategy into actionable plans.
• Excellent organizational and time management skills, including the ability to prioritize and manage multiple tasks and expectations in a fast-paced environment.
• Ability to work independently and in cross-functional teams with moderate supervision.
• Strong verbal and written communication skills; able to communicate honestly, transparently, and effectively with peers, department management, and cross-functionally, including advanced technical document writing.
• Knowledge of the relationship between manufacturing processes, ERP, PCS, and MES preferred.
• Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques preferred.
• Experience with manufacturing boundary systems preferred.
• Ability to travel 10%-15% of time.

• Bachelor's degree required in Engineering, Biological/Life Sciences, Chemistry, Biochemistry, or related field, or equivalent combination of education and work experience.
• A minimum of two (2) or more years of manufacturing support, manufacturing engineering, or related experience in the biotechnology or pharmaceutical industry.
• Knowledge of cGMPs and multi-national biopharmaceutical regulations; Cell Therapy or Biologics experience required.
• Hands-on experience with SQL, Python (or R), and associated data science packages required.
• Experience with any of the following: HP ALM, Electronic Document Management Systems, and Change Management Systems
• Advanced knowledge of MS Office Applications; proficiency with reporting/visualization tools (e.g., Tableau, Power BI).

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.