Engineering Manager (Owner’s Representative)

Role Overview

• The Engineering Manager will serve as the Owner’s Representative and provide leadership, governance, and technical oversight for engineering activities across the project life cycle.

• Protect the Owner’s business, operational, safety, quality, cost, schedule, and regulatory interests while coordinating design firms, contractors, vendors, site stakeholders, and internal functions.

• Verify that technical solutions are fit for purpose, compliant, constructible, maintainable, and aligned with approved project objectives without assuming the Engineer of Record’s design responsibility.

Key Responsibilities

• Act as the Owner’s primary engineering representative and single point of coordination for multidisciplinary engineering matters.

• Translate the Owner’s business, manufacturing, operational, maintenance, safety, quality, and regulatory requirements into clear project criteria and engineering priorities.

• Establish and maintain the engineering execution strategy, design-governance process, decision authorities, review gates, deliverable requirements, and technical interfaces.

• Direct and coordinate the activities of engineering consultants, the Engineer of Record, construction partners, vendors, and specialist advisors while preserving clear contractual accountability.

• Monitor engineering performance against approved scope, budget, schedule, quality, and risk objectives; identify variances and lead timely recovery or mitigation actions.

• Facilitate timely technical decisions, document Owner approvals, and escalate material issues with clear options, impacts, and recommendations.

• Lead alignment among operations, maintenance, automation, quality, validation, EHS, procurement, construction, commissioning, and project controls stakeholders.

• Oversee engineering from feasibility and conceptual design through detailed design, procurement, construction, commissioning, qualification, validation, and turnover.

• Plan and lead multidisciplinary reviews of calculations, specifications, drawings, models, equipment packages, and reports at defined project milestones.

• Verify compliance with applicable codes, standards, cGMP requirements, regulatory guidance, Owner standards, and sanitary-design principles.

• Provide Owner-side engineering support during procurement, construction, installation, testing, startup, commissioning, qualification, and validation.

Key Deliverables & Systems to Be Governed

• User requirement specifications, project design criteria, basis-of-design documents, and engineering execution plans.

• Process and utility flow diagrams, P&IDs, mass and energy balances, equipment/instrument lists, line lists, and control narratives.

• Equipment specifications, datasheets, bid packages, technical bid evaluations, vendor documents, and procurement recommendations.

• Facility layouts, 3D models, piping/utility designs, clean systems, process systems, automation interfaces, and materials storage/distribution systems.

• Construction work packages, field changes, punch lists, turnover packages, O&M documentation, and as-built records.

• Commissioning, qualification, validation, startup, testing, training, and operational-readiness documentation.

Qualifications & Requirements

• Bachelor’s degree or higher in Chemical, Mechanical, Electrical, Civil, or another relevant engineering discipline.

• Professional Engineer (PE) license preferred but not required.

• Minimum 15 years of progressive engineering experience, including substantial responsibility for multidisciplinary capital projects in the pharmaceutical, biotechnology, biopharmaceutical, specialty chemical, or other regulated manufacturing industries.

• Demonstrated experience serving as an Engineering Manager, Owner’s Representative, Design Manager, or comparable technical leader on complex projects.

• Strong working knowledge of cGMP requirements, equipment qualification and validation, process and clean utilities, automation interfaces, facility systems, construction, commissioning, and operational readiness.

• Experience with design-bid-build, design-build, EPCM, construction-management, or integrated project-delivery models.

• Ability to distinguish Owner oversight from the contractual responsibilities of designers, the Engineer of Record, contractors, and vendors.

• Strong commercial awareness and ability to evaluate technical decisions in relation to cost, schedule, risk, procurement, contracts, and lifecycle value.