Remote Director, GMP Engineering & Project Delivery

SURGE Staffing; Ormond Beach (FL); Remoto; USD 180.000 - 280.000; Tempo pieno

Vantaggi offerti da questo lavoro

Travel opportunities

Descrizione del lavoro

SURGE Staffing seeks a Director of GMP Engineering & Project Delivery to lead an integrated delivery function for regulated environments. You will shape strategy, staffing, and commercial approach across design, procurement, installation, qualification, and turnover, partnering with CQV, Field Service, and Certification teams.

You will combine deep GMP facility expertise with proven ability to build teams, manage third-party partners, and deliver projects on quality, schedule, and financial

Competenze

• Bachelor's degree in mechanical, chemical, biomedical, industrial engineering, or related field.
• Minimum 12 years delivering GMP facilities, equipment, or processes in pharma/biotech/life sciences.
• At least 5 years leading multidisciplinary teams.
• Deep CQV lifecycle knowledge including IQ/OQ/PQ and requalification.
• Experience delivering CSV/CSA for GxP systems.
• Familiarity with 21 CFR Part 11, EU GMP Annex 11, data integrity standards.
• Experience with cleanrooms, isolators, or controlled environments.
• Proven vendor management of automation/controls vendors.

Mansioni

• Build GMP delivery function, including service offerings and staffing.
• Define repeatable delivery approach linking engineering to turnover.
• Align standards across CQV, Field Service, and Certification.
• Recruit and mentor multidisciplinary technical talent.
• Serve as technical authority for GMP facility and equipment design.
• Establish engineering and validation standards and templates.
• Oversee CSV/CSA risk-based validation strategies.
• Manage data integrity, audit trails, and validated systems.
• Coordinate procurement, installation, and transition to qualification.
• Own function P&L, revenue, utilization, and gross margin.

Conoscenze

GMP facilities

CQV lifecycle

CSV/CSA

Leadership

Vendor management

Budget ownership

Regulatory knowledge

Cross-functional collaboration

Project delivery

Travel readiness

Formazione

Bachelor's degree in engineering

Strumenti

Microsoft Office

Descrizione del lavoro

SURGE Staffing seeks a Director of GMP Engineering & Project Delivery to lead an integrated delivery function for regulated environments. You will shape strategy, staffing, and commercial approach across design, procurement, installation, qualification, and turnover, partnering with CQV, Field Service, and Certification teams.

You will combine deep GMP facility expertise with proven ability to build teams, manage third-party partners, and deliver projects on quality, schedule, and financial