Manufacturers are the backbone of innovation—powering industries, improving lives, and keeping the world moving forward. That’s where Flexware Innovation comes in. Behind every great product is a complex web of machines, technology, data, and people working together to make it happen. Flexware partners with manufacturers to guide their strategy and execute the solutions that bring it to life.
Founded in 1996, Flexware’s teams of talented advisors and engineers leverage technology across industrial controls, manufacturing systems integration, software development, data engineering and management, and the ever-evolving landscape of emerging technologies.
Flexware is made up of problem-solvers, builders, and collaborators who care deeply about doing work that matters. We roll up our sleeves, dive into the details, and create solutions that stand the test of time, because our customers count on us to keep production moving.
Today, Flexware is growing with fresh momentum and purpose. We’re investing in innovation, in our people, and in a culture where you can do your best work while living a balanced, meaningful life
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.
Pharma Strategy & Service Development
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
Pharma Client Engagement & Delivery
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
Business Development & Advisory Selling
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
Delivery Team Leadership & Cross-Practice Mentoring
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
Financial Management
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
Pharma Thought Leadership & Industry Presence
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
Collaboration & Innovation
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
**Please note that we are not interviewing candidates that require sponsorship now or in the future**
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
Pharma Operations Expertise
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
Digital & Technical Expertise
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
Industry Knowledge
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
Consulting & Business Skills
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
Leadership & Interpersonal
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
Preferred Qualifications
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
Work Environment & Travel
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
If you're interested in this role, we're excited to start a conversation with you! Please reach out to Lindsay Imhoff at
[email protected]. Your inquiry and conversation will be treated with confidentiality, and we will not share your information with others.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected status.
