Director of Capital Project Engineering – Pharmaceutical

The International Society for Pharmaceutical Engineering, Inc.; Spokane (WA); Hybrid; USD 200,000 - 250,000; Full time

Benefits offered by this job

Full Benefits from Day 1

Generous Relocation package

Visa support: H1B/TN1

Job summary

The International Society for Pharmaceutical Engineering, Inc. invites a Director of Capital Project Engineering to lead site capital strategy at its Spokane, WA facility.

You will govern programs from concept to commissioning, ensuring safety, quality, and on-budget delivery in a fast-paced CDMO environment. This role requires 12+ years in capital projects, strong leadership of engineering teams, and collaboration across Finance, Quality, and Operations.

Qualifications

• BS in Engineering, Construction/Project Management, business or related field.
• 12+ years in capital projects, program, engineering, CAPEX, or asset management in regulated manufacturing.
• 5+ years in BioPharma industry.
• 5+ years leading a dept. of project/program engineers.
• Experience delivering large, complex capital projects with scope, schedule, budget and risk.
• Experience with capital budgeting, forecasting, project controls, contractor mgmt, and exec reporting.
• Knowledge of cGMP, commissioning, qualification, change control, and project turnover in pharma manufacturing.
• Proven leadership experience managing engineering teams in a fast-paced CDMO environment.
• Fluent in French is a huge plus.
• Experience with PM software - Clarity or similar.

Responsibilities

• Lead capital portfolio strategy, governance, and long-range planning.
• Oversee projects from concept through turnover, with clear charters and acceptance criteria.
• Ensure project controls, risk plans, and cost management across programs.
• Coordinate with Engineering, QA, Validation, EHS, Supply Chain, and Finance.
• Provide portfolio visibility and executive reporting on scope, schedule, and benefits.

Skills

PMO Leadership

Leadership

Project Management

Capital Projects

Vendor Oversight

Communication

Education

BS in Engineering

MBA (optional)

Tools

Clarity

PM Software

Capital Budgeting Tools

Job description

Our client – a global and growing BioPharma CDMO company needs a Director of Capital Project Engineering at their expanding plant in WA state. Excellent Salary up to $250K + Bonus + Full Benefits (from Day 1) + Generous Relocation package. Client will support H1B or TN1 Visa if needed.

Job Posting # 2725

Job Title:

Director of Capital Project Engineering – Pharmaceutical

Location:

Spokane, WA

Relocation:

Theclient offers a generous relocation package.

Compensation:

Salary range up to $250K base + Annual Bonus (20%)

Full Benefits:

Medical, Vision, Dental, 15 days' vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries including around 1,300 people at this site in Spokane, WA. This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info:

Lead the Project Management and PMO group at their main plant in Washington state and also a smaller plant in Quebec, Canada.

Note1:

The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are expanding again with a 4th line at Spokane, WA and also in Canada

Note 2:

The client will support TN1 visa for Canadian citizens and also H1B Visa Transfers if needed.

Note 3:

The right person with extensive PM, PMO. leadership and department management experience from Engineering consulting or Construction management companies but for BioPharma clients.

Summary:

• The Director, Capital Projects provides strategic leadership and governance for the capital portfolio across the CMO business and the development of capital manage across the project lifecycle that integrates with the corporate PMO.
• The role is accountable for capital planning, prioritization, project and program execution, financial stewardship, and consistent project controls from concept through commissioning, qualification support, turnover, and closeout.
• The Director leads project and program management resources and partners cross-functionally to ensure capital investments are safe, compliant, cost-effective, aligned with business priorities, and delivered on schedule and within approved budgets.

Job Description:

Capital Portfolio Strategy & Governance

• Lead the site capital planning process, including project intake, business case development, prioritization, annual budgeting, forecasting, and long-range capital planning.
• Establish and maintain project governance, stage-gate expectations, engineering standards, and consistent project management practices across the capital portfolio.
• Provide portfolio-level visibility to scope, schedule, cost, risk, resource requirements, and benefits realization; escalat material risks and recommend corrective actions. Project & Program Delivery
• Oversee capital projects and programs from concept and design through procurement, construction, commissioning, qualification support, operational turnover, and closeout.
• Ensure projects have clear charters, approved scope, schedules, budgets, risk plans, change controls, and documented acceptance criteria.
• Establish project controls processes that are meaningful, pragmatic and in alignment with PMO business deliverables.
• Partner with Engineering, Maintenance, Manufacturing, Quality, Validation, EHS, Supply Chain, Finance, and Procurement to coordinate execution and minimize operational disruption.

Financial & Asset Management

• Manage the capital portfolio budget in partnership with Finance, including estimates, cash-flow projections, commitments, accruals, forecasts, and variance reporting.
• Engage in industry standard asset lifecycle and depreciation discussion with finance.
• Ensure current and accurate project costing and support financially sound investment decisions through total-cost-of-ownership analysis.

People Leadership

• Lead, coach, and develop project and program managers and project controls resources; establish clear goals, performance expectations, and development plans.
• Build resource plans and delivery capabilities that support the site capital roadmap and promote accountability, collaboration, technical rigor, and continuous improvement.

Compliance, Safety & Vendor Oversight

• Ensure capital work complies with cGMP requirements, applicable regulatory expectations, company standards, approved quality systems, and EHS requirements.
• Oversee contractor, consultant, engineering firm, and equipment vendor performance, including selection support, deliverables, safety, quality, schedule, and commercial outcomes.
• Support audits, inspections, deviations, CAPAs, and change controls associated with capital projects and asset implementation.

Candidate Must Have:

• BS in Engineering, Construction/Project Management, business or related field.
• 12+ years of progressive experience in capital project, program, engineering, CAPEX or asset management within a regulated or complex manufacturing environment.
• 5+ years of experience in the BioPharma Industry.
• 5+ years of leadership managing a Dept. of project/program engineers & multidisciplinary teams.
• Demonstrated delivery of large, complex capital projects and portfolios with accountability for scope, schedule, budget, risk, and stakeholder alignment required.
• Experience with capital budgeting, forecasting, project controls, contractor management, and executive-level portfolio reporting required.
• Working knowledge of cGMP, commissioning, qualification, change control, and project turnover in pharmaceutical or biopharmaceutical manufacturing required.
• Proven leadership experience managing engineering teams and programs
• Ability to work in a fast-paced Pharma contract Manufacturing organization (CDMO)

Candidate Nice to Have:

• Advanced degree in Engineering or MBA
• Pharmaceutical aseptic processing and equipment lifecycle Mgmt.
• Professional Engineer – PE License.
• Lean six Sigma certification.
• PMI Project Management Professional – PMP
• Experience implementing project portfolio management systems, governance models, or standardized stage-gate processes.
• Experience managing projects in Quebec, Canada if needed.
• Fluent in French is a huge plus.
• Experience working with Project Management software - Clarity or other industry leading PGM tools.

Keywords:

Projects, Assoc. Director, Manager, PMO, Program, PMP, PE, Six Sigma, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Clarity, French, Canada, CAPEX