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.
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.
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.
Requirements
& 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.