Digital Transformation Lead - Pharma

Amaris Consulting is looking for a  Digital Transformation Lead  to assess the digital maturity of a Canadian pharmaceutical contract manufacturer and define its multi-year digital roadmap.

The site is converting to aseptic liquid filling and expanding its filling capacity. Before introducing advanced technologies, it needs strong foundations for data capture, traceability, integration and governance.

You’ll assess how data is collected, reviewed and used across the shop floor, then define the path from the current environment to a connected and efficient operation. The role combines technology, stakeholder management and change leadership.

You’ll be the client’s single point of contact for this scope and will meet the client during the selection process.

Your responsibilities
Digital maturity assessment

Map the current environment across the shop floor, IT and operational technology, including equipment connectivity, control systems, MES, SAP, LIMS, QMS, data historians, paper records and network infrastructure.

Assess the site’s digital maturity against a recognised reference model, such as ISA-95 or an industry digital plant maturity model.

Trace how data is captured, recorded, reviewed and trended.

Identify gaps in data traceability, data integrity and system integration.

Interview and run workshops with operations, quality, engineering, maintenance, IT and site leadership.

Document current pain points, business needs and transformation priorities.

Digital roadmap

Define the target state for shop floor data collection, data structures, equipment connectivity and system integration.

Describe how equipment, MES and SAP should exchange data in both directions.

Build a phased, multi-year roadmap that starts with core foundations before advanced analytics and AI.

Set out dependencies, sequencing, quick wins and key decision points.

Estimate the effort, cost range, risks and expected benefits of each initiative.

Support business cases for site leadership.

Make sure the new aseptic filling capacity is designed with the target architecture in mind.

Define the CSV and data integrity implications of each initiative, in line with GAMP 5 and FDA 21 CFR Part 11.

Recommend technologies and vendors based on the site’s needs.

Support vendor assessments and selection when required.

Stakeholder management and change

Act as the client’s main contact for this scope.

Manage expectations and build sponsorship among site leadership and key business functions.

Explain the reasons for change in practical terms.

Involve end users in the design and prepare teams for new ways of working.

Define training and adoption activities for the roadmap.

Present the assessment findings, target state and roadmap to site leadership and steering committees.

Your profile
Required experience

Degree in engineering, computer science, information systems or a related field.

10 or more years of experience in pharmaceutical or biotech manufacturing.

At least 5 years of experience in manufacturing IT, operational technology or digital transformation.

Experience leading a site-level digital maturity assessment or digital roadmap in a GMP environment.

Hands‑on knowledge of MES platforms such as Syncade, PAS‑X, POMSnet or Opcenter, including their integration with ERP systems, ideally SAP.

Strong understanding of shop floor data architecture, including control systems, data historians, industrial connectivity and the ISA‑95 model.

Working knowledge of CSV, data integrity, ALCOA+, GAMP 5 and FDA 21 CFR Part 11.

Experience running workshops and leading change with operations, quality and IT teams.

Confidence presenting to site leadership and steering committees.

Eligibility to work in Canada.

Nice to have

Experience with a CMO or CDMO, or with a site at an early stage of…