Engagement Manager - Pharmaceutical Manufacturing

Description

We are seeking an exceptional Engagement Manager to anchor the pharmaceutical manufacturing vertical within our Digital Transformation and Industrial AI practice. Reporting to the Vice President, Digital Transformation & Industrial AI, this role combines portfolio-level engagement leadership and pharma business development with deep technical credibility in operations engineering and digital transformation across regulated manufacturing environments. The successful candidate will oversee a portfolio of pharma consulting engagements, build and lead engagement teams drawn from across the practice, drive pharma business development as a senior advisory voice at client organizations and establish Flexware's point of view on pharma Smart Manufacturing.

You will bring operations engineering and pharma industry depth to shape engagements and lead delivery teams in execution, sitting at the intersection of pharma operations engineering and digital transformation. You will break down the silos between operations, engineering, quality, and IT that ISPE has identified as the central barrier to Pharma 4.0 adoption. The role anchors in pharmaceutical manufacturing with natural applicability to adjacent regulated life sciences operations including medical device, biologics, and contract development and manufacturing organizations.

• Partner with the Vice President to define and evolve Flexware's pharma manufacturing services strategy, aligned with Hitachi's life sciences priorities, JR Automation's pharma equipment portfolio, and the broader Smart Manufacturing service portfolio

• Design pharma-specific service offerings addressing use cases such as OEE / Technical Efficiency uplift, ramp performance recovery, predictive maintenance, predictive quality, MES and electronic batch records, PAT, digital twins, and advanced process control in regulated environments

• Identify pharma market opportunities and competitive positioning; shape the pharma capability roadmap for the practice

• Evaluate and recommend pharma-relevant technology vendors and strategic partners across Pharma 4.0 platforms

• Oversee a portfolio of active pharma engagements with accountability for delivery quality, strategic alignment, and client satisfaction across the portfolio; step in personally on executive-level escalations and complex client situations

• Lead senior-level pharma consulting engagements including operational performance diagnostics, OEE / Technical Efficiency gap analysis, ramp performance recovery, Pharma 4.0 maturity assessments, roadmap creation, and business case development for pharmaceutical manufacturers, CDMOs, and pharma equipment OEMs

• Direct pharma digital transformation implementation projects encompassing data strategy, architecture design, technology selection, solution configuration, validation strategy, and deployment

• Conduct structured on-site operational diagnosis at pharma manufacturing and contract manufacturing facilities – observing line operations, interviewing operators and process engineers, and triangulating direct observation against historian, alarm, event, and OEE data to confirm root causes

• Translate operations findings into digital solution requirements and translate digital solution constraints back into operational terms that line leaders, plant managers, and operations directors can act on

• Build and maintain trusted advisor relationships with VP-level and senior operational leaders at pharma client organizations

• Operate in a two-in-the-box model with Flexware's sales organization at pharma accounts – Sales leads the client relationship and account strategy; you provide senior advisory presence, convert qualified opportunities into scoped engagements, and follow through into delivery

• Show up autonomously at pharma client sites alongside Sales to advise operations and digital leaders, surface needs, and shape demand for Flexware services

• Scope and structure complex pharma engagements; lead proposal development, solutioning, and pricing input in collaboration with Sales and practice leadership

• Contribute meaningfully to the pharma vertical's revenue and pipeline objectives through advisory conversion, repeat engagement growth, and net-new opportunity development

• Provide consulting-led perspective into account strategy and pursuit qualification with Sales; identify follow-on opportunities surfaced during delivery and hand back to Sales for relationship-level pursuit

• Serve as the pharma subject matter expert in capability presentations, proposals, and pursuit work across the practice

• Lead delivery across a portfolio of pharma engagements with rotating engagement teams of industrial AI consultants, data scientists, and technologists drawn from across the practice; set direction, prioritization, and quality expectations across the portfolio

• Mentor consultants and technologists across the practice on pharma operations context – validation realities, GMP constraints, and the operator-level dynamics that determine whether a digital solution succeeds in production; cultivate pharma capability in practitioners not formally aligned to the vertical

• Establish quality standards, methodologies, and best practices for pharma engagements; conduct periodic engagement quality reviews

• Grow into direct people leadership within the Smart Manufacturing service line, based on service line growth and market demand – hiring, developing, and managing pharma-focused practitioners

• Partner with JR Automation and other Hitachi equipment teams on pharma-line equipment performance, FAT/SAT-to-production transitions, and equipment-side root cause analysis

• Manage pharma engagement financial targets – revenue, margin, and engagement-team utilization – against the targets defined for the engagement portfolio

• Accountable for budget and forecast discipline on engagements within the pharma portfolio; manage scope, resource utilization, and burn rates against engagement margin targets

• Contribute to firm-level business planning, pharma investment cases, and resource allocation decisions; provide input on pricing strategies and commercial models for pharma consulting and implementation services

• Optimize service delivery efficiency and margin performance across the pharma portfolio

• Own Flexware's point of view on pharma Smart Manufacturing and Pharma 4.0; develop and publish thought leadership content including whitepapers, case studies, and articles

• Represent Flexware at pharma industry conferences, client events, and speaking engagements; develop a recognized industry presence in pharma Smart Manufacturing

• Drive practice-level methodology, tooling, and IP investments in pharma – codifying diagnostic approaches, reference architectures, solution accelerators, and engagement playbooks

• Contribute to marketing materials and intellectual capital that differentiate Flexware's pharma manufacturing capabilities

• Identify opportunities to evolve pharma services into product or managed service offerings; contribute to development efforts with Flexware's product and managed services teams

• Support pharma initiatives across JR Automation and Hitachi portfolio companies; participate in cross-company opportunity development

• Contribute to ecosystem partnerships with pharma-relevant AI and Pharma 4.0 technology providers and complementary service firms

• Bachelor's degree in Engineering (Chemical, Mechanical, Industrial, Bioprocess, or related discipline) or equivalent experience; advanced degree (MS, MBA, PhD) preferred

• 10+ years of professional experience combining hands-on pharmaceutical manufacturing operations and digital transformation or smart manufacturing delivery

• Minimum 5 years of operations leadership, consulting, or implementation experience in pharmaceutical manufacturing, contract manufacturing, or pharma equipment OEM environments, with demonstrated manufacturing shopfloor depth – operating, optimizing, or implementing systems on a regulated production line

• Demonstrated track record leading engagement teams and delivering complex digital transformation projects from strategy through implementation in pharma or adjacent regulated industries

• Proven ability to build and develop trusted advisor relationships with VP-level operations, engineering, and digital leaders at pharmaceutical or life sciences clients

• Deep working knowledge of cGMP, computer system validation (CSV), Computer Software Assurance (CSA), GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, ICH Q10, ISA-88 / ISA-95, and FDA / EMA regulatory expectations as they affect digital systems and operational data

• Familiarity with pharma manufacturing modalities – fill-finish, oral solid dose, biologics, API, packaging – with depth in at least one

• Understanding of pharma equipment lifecycle: FAT/SAT, IQ/OQ/PQ, validation maintenance, change control, and tech transfer

• Fluency in pharma operational KPIs: OEE / Technical Efficiency, right-first-time, yield, batch cycle time, deviation rates, changeover performance

• Knowledge of the Pharma 4.0 framework as articulated by ISPE, the maturity model, and the operating-model implications for organizations pursuing digital transformation in regulated environments

• Deep understanding of pharma-relevant industrial AI use cases including predictive maintenance, predictive quality, process optimization, advanced process control, and digital twins – and where the regulatory boundaries lie in validated environments

• Hands-on experience with manufacturing data and OEE / Digital Performance Management platforms

• Familiarity with industrial systems in regulated context: SCADA, DCS, MES, historians, electronic batch records (EBR), LIMS, IoT platforms, PAT, serialization, and environmental monitoring

• Understanding of OT/IT integration challenges in pharma – network segmentation, data integrity controls, validated data flows, and MLOps in regulated environments

• Knowledge of AI/ML technologies, platforms, and deployment architectures (edge computing, cloud, hybrid) and their applicability within validated environments

• Expert understanding of pharma manufacturing operational challenges, KPIs, and value drivers across discrete, process, and hybrid environments

• Awareness of pharma manufacturing economics: capacity constraints, OEE-to-revenue conversion, validation cost drivers, and the operational cost of compliance

• Familiarity with industrial automation systems including PLC, SCADA, DCS, MES, AMRs, and historians in regulated pharma contexts

• Understanding of CDMO and contract manufacturing operations – including the dynamics that differentiate brand-owner sites from contract manufacturing partners

• Exceptional problem-structuring and analytical skills with ability to synthesize complex operational issues into testable hypotheses and prioritized remediation paths

• Outstanding communication and presentation skills, with demonstrated ability to engage C-suite and VP-level executives and to operate fluently with plant operators on one end of the spectrum and pharma operations executives on the other

• Strong business acumen including financial modeling, ROI analysis, business case development, and commercial strategy

• Proven ability to develop compelling proposals, business cases, and client-facing materials

• Track record of successful business development and client relationship management in industrial or life sciences accounts

• Experience leading and developing high-performing engagement teams in a consulting or professional services context

• Executive presence with ability to build credibility with senior pharma stakeholders – operations VPs, plant directors, digital transformation sponsors, and quality leaders

• Collaborative mindset with proven ability to work across organizational boundaries – operations, engineering, quality, and IT

• Entrepreneurial orientation with comfort in ambiguous, rapidly evolving environments

• Strong project and program management capabilities across multiple concurrent engagements

• Direct experience implementing OEE or Digital Performance Management solutions on a pharma production line

• Experience working with pharmaceutical CDMOs or supporting contract manufacturing operations

• Background in process engineering, manufacturing engineering, or operations engineering within pharma or biotech

• Experience with Hitachi technologies, JR Automation equipment, or with pharma equipment OEMs

• Certifications in Lean Six Sigma, ISPE GAMP, PMP, or related disciplines

• Published thought leadership or speaking experience at pharma industry conferences

• Active participation in industry organizations (ISPE, ISA) or standards-setting bodies

• Experience building or scaling vertical practices within a consulting organization

• Demonstrated proficiency leveraging generative AI tools to enhance productivity, including experience establishing best practices for responsible AI tool usage within professional services terms

• This is a remote position with flexibility to work from anywhere within the continental United States

• Periodic travel to Flexware headquarters in Fishers, IN is expected

• Travel to client sites is expected at approximately 30-40% depending on project assignments