Director of Engineering & Project Delivery

Director Engineering & Project Delivery

Location: Remote, with travel to headquarters in Ormond Beach, FL, and customer sites
Reports To: Chief Strategy & Services Officer
Employment Type: Full-time
Travel: Up to 40%, domestic and international
Schedule: Five days per week; occasional extended hours, weekends, and off-hours customer support required

Position Summary

We are seeking an experienced Director of GMP Engineering & Project Delivery to build and lead an integrated delivery function supporting customers in regulated pharmaceutical, biotechnology, medical device, and life sciences environments.

This leader will establish the strategy, standards, staffing model, and commercial approach that connect design, procurement, fabrication, installation, qualification, validation, and turnover into a coordinated offering. The role partners closely with established Commissioning, Qualification & Validation (CQV), Field Service, and Certification teams while those groups retain responsibility for their respective operations.

The ideal candidate combines deep technical expertise in GMP facilities, equipment, and computerized systems with experience building technical organizations, managing third-party engineering partners, and delivering projects against quality, schedule, and financial commitments.

Key Responsibilities

Delivery Strategy & Team Development

• Build the GMP delivery function, including service offerings, operating structure, staffing plans, billing rates, utilization targets, and phased hiring criteria.
• Establish a repeatable delivery approach that connects engineering, manufacturing, installation, qualification, and turnover.
• Align standards, resources, and customer commitments across CQV, Field Service, Certification, and other internal teams.
• Determine which capabilities to maintain internally and which to support through qualified partners.
• Partner with functional leaders to recruit, develop, and mentor multidisciplinary technical talent.
• Create competency frameworks and career development paths to support long-term team growth.

Engineering, Qualification & Validation

• Serve as the technical authority for GMP facility and equipment design, including user requirements, basis of design, design rationale, and formal design reviews.
• Establish engineering and validation standards, document templates, and review procedures.
• Develop risk-based approaches to computer system validation (CSV) and computer software assurance (CSA) in coordination with CQV.
• Provide oversight of data integrity, electronic records and signatures, audit trails, and validated computerized systems.
• Resolve complex technical issues involving cleanroom classification, containment, air handling, utilities, material and personnel flow, and contamination control.
• Support the expansion of certification services, including biological safety cabinets, HEPA filtration, cleanroom classification, vaporized hydrogen peroxide biodecontamination, and requalification.
• Ensure work meets applicable cGMP requirements and relevant standards, including FDA regulations, EU GMP Annexes 1 and 11, ISO 14644, NSF/ANSI 49, GAMP 5, and ISPE guidance.

Vendor & Project Oversight

• Select, qualify, and technically manage vendors supporting automation, controls, and process engineering.
• Define vendor scope, evaluate proposals, review technical specifications, and approve deliverables.
• Review vendor designs, software and control specifications, protocols, and turnover packages for alignment with project qualification requirements.
• Maintain approved vendor and supplier qualification programs in partnership with Quality.
• Establish project controls for schedules, costs, earned value, risks, and change management.
• Manage change orders for internally delivered work, including scope identification, pricing, and customer discussions.
• Coordinate procurement, expediting, installation supervision, and transition to qualification with existing corporate functions.

Financial & Customer Leadership

• Own financial performance for the function, including revenue, billable utilization, realized billing rates, gross margin, and EBITDA contribution.
• Support sales and proposals with technical scope, pricing, resource plans, and customer presentations.
• Serve as a senior technical contact for customers, explaining engineering decisions, validation approaches, corrective actions, and recommendations.
• Partner with Quality, Legal, and Risk to support appropriate quality systems and professional liability coverage for engineering, qualification, and validation services.

Required Qualifications

• Bachelor’s degree in mechanical, chemical, biomedical, industrial engineering, or a related technical discipline.
• At least 12 years of progressive experience delivering GMP facilities, equipment, or processes within pharmaceutical, biotechnology, advanced therapy medicinal products (ATMP), medical device, or high-containment life sciences environments.
• At least five years leading multidisciplinary technical teams, including hiring and developing engineers and qualification personnel.
• Deep understanding of the CQV lifecycle, including commissioning strategy, IQ/OQ/PQ, and requalification.
• Demonstrated experience delivering CSV or CSA for GxP computerized systems.
• Working knowledge of 21 CFR Part 11, EU GMP Annex 11, ALCOA+ principles, and data integrity expectations.
• Experience with cleanrooms, isolators, restricted access barrier systems, biological safety cabinets, or other controlled and containment environments.
• Experience managing third-party automation, controls, or process engineering vendors on capital projects.
• Proven ability to establish technical processes, standards, staffing models, and delivery capabilities.
• Prior profit-and-loss or cost-center ownership, including responsibility for budgets, utilization, and margins.
• Strong customer communication, commercial judgment, and cross-functional leadership skills.
• Proficiency with Microsoft Office applications and familiarity with project controls and validation lifecycle management platforms.
• Valid driver’s license, acceptable driving record, valid passport, and ability to meet travel requirements.
• Successful completion of a background check and drug screening.

Preferred Qualifications

• Advanced technical degree or MBA.
• Experience building an engineering, delivery, or validation function within an established manufacturer.
• Field certification experience involving NSF/ANSI 49, HEPA filters, biological safety cabinets, or cleanroom classification.
• Familiarity with certification and accreditation requirements.
• Experience delivering modular, mobile, or prefabricated GMP facilities.
• Experience in ATMP, cell and gene therapy, aseptic fill-finish, or hospital pharmacy compounding under USP 797/800.
• International project experience, particularly in the Middle East or Asia-Pacific.
• Relevant professional credentials, such as PE, PMP, CQE, CSQE, or ISPE/PDA certifications.

Physical Requirements & Working Conditions

• Perform site inspections requiring standing, walking, kneeling, bending, reaching, and climbing ladders or stairs.
• Work at active construction sites, in mechanical rooms, and occasionally in confined or elevated spaces.
• Work in varying temperatures and noise levels.
• Wear required cleanroom garments and personal protective equipment.
• Lift and carry up to 25 pounds, with assistance for heavier items.
• Travel by car and air, including overnight stays and extended international assignments.

Work Environment

Join a collaborative organization that values integrity, accountability, initiative, and innovation. This role offers the opportunity to build a growing technical function, develop talent, and lead complex projects that support critical regulated environments.

IND3

Originally posted on Himalayas