Apple & Associates – Digital Analyst – MES – Lexington, MA

Job title: Digital Analyst - MES

Company: Apple & Associates

Job description: The Digital Analyst will deliver value at MA Biologics Operations plants and warehouses by leveraging existing and emerging digital technologies. As a member of site Data, Digital, and Technology (DD&T) team, you will collaborate with our business partners to transform the facility into a future-facing, highly efficient and effective organization.

This person will:
• drive digital innovation & automation and new ways of working with progressive technologies and platforms e.g. MES, IoT, AI companion, AR/VR/XR, etc.
• actively participate in the deployment and support of MES and above mentioned technologies by collaborating with cross-functional teams.

ACCOUNTABILITIES:

 Work with MES system owner and business owner to prioritize MES projects and operations

 Engage with MBR designers, IT infrastructure team, Quality, Validation and global teams to

coordinate and deploy technical aspects of MES system such as interfaces, enhancements

and any fixes.

 Manage MES incidents/tickets and escalate issues to MES System Owner.

 Work with site DD&T team and business leaders to identify any relevant use cases and continuous improvement opportunities for existing technology solutions or brainstorm solutions to automate and simplify repetitive tasks

 Be knowledgeable of existing and emerging digital technology platforms and their application to plant/warehouse setting specifically in manufacturing operations, engineering, and supply chain

 Apply a structured agile methodology for system changes and support change management activities

 Maintain/develop strong relationships with stakeholders to facilitate successful collaborations

CORE ELEMENTS RELATED TO THIS ROLE:

MES PAS-X; Digital transformation; Change agent; Problem solver.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

Software project lifecycle and experience in MES PAS-X.

Experience in Computer System Validation (CSV) for manufacturing systems.

Industry 4.0 technologies such as IoT, RPA, AI companion, AR/VR/XR, Biometrics, Data Analytics, Predictive technologies, etc.

Exhibit a continuous improvement (CI) mindset to automate and simplify repetitive tasks.

Be able to independently troubleshoot issues (where to look and what to look for), determine root-

case (e.g. by process of elimination), and implement resolution by “putting two and two together” i.e. draw a conclusion based upon given evidence.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

Ability to persuade others to follow. Career driven, self-motivated, willing to learn new technologies and skills.

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

Propose technology solutions, once approved by site & DD&T leadership, the candidate must execute/deliver with autonomy. Decisions will impact plant of ~800 colleagues and could lead to improvements across network of plants.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

 Bachelor's degree in information technology, computer science, engineering, or a related study (required)

 Working knowledge and experience with following technologies or areas (required):

o MES System such as PAS-X, Syncade, POMSnet, etc.

o IT infrastructure and virtual environment

o System integration and interfaces

 Working knowledge and experience with one of the following technologies (preferred):

o SAP ERP system

o 3D Tour or any of the AR/VR/XR technology product(s)

o RPA tool such as UIPath

o Biometrics based authentication or equivalent

o AI Companion

o IoT technology and associated product(s)

o Data Anlytics data lake

 Overall 5 years experience at a Pharmaceutical Biologics Manufacturing facility or in a consulting role (preferred).

 Familiarity with following SDLC and GxP processes used in Pharmaceutical industry (preferred):

o Computerized Systems Validation (CSV)

o 21 CFR Part 11 regulations and Data Integrity compliance

 Familiarity with following tools and processes (preferred):

o ServiceNow - ITIL processes such as Incident Management, Change Management, Request Management, Asset and Configuration Management (CMDB)

o Veeva EDMS - Document Workflows

o MS Visio and Project

NO SPONSORSHIP AVAILABLE

Expected salary:

Location: Lexington, MA

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