Director, GMP Systems Delivery in Ormond Beach, Florida at Germfree Laboratories Inc

Job Title: Director, GMP Systems Delivery

Reports to: Chief Strategy & Services Officer

Location: Remote, with travel to Germfree HQ and Client Site

Work Schedule: 5 days/week; extended hours, weekends, and off-hours client coverage may be required at times.

Travel Requirements: Willingness and ability to travel up to 35% of the time, domestic and international, to project sites and client locations.

Job Overview: At Germfree, you will be recognized as a leading expert in an environment that values grit, integrity, ownership, and innovation—principles that lie at the core of our culture. We are committed to engineering and developing cutting-edge solutions that create a tangible impact in the real world.

As the Director, GMP Systems Delivery, you will build and lead Germfree’s internal GMP delivery capability, providing a suite of services to CGMP-regulated customers. You will own the overall strategy for how Germfree delivers CGMP systems — the operating model, standards, and commercial approach that connect design, fabrication, installation, qualification, and turnover into a single offering — working closely with the CQV and Field Service groups, who own their respective operations. You will also own the selection and technical management of the third-party vendors who deliver automation, controls, and process engineering scope — holding their work to Germfree standards rather than accepting it as delivered.

You bring deep, practical command of how GMP facilities, equipment, and computerized systems are designed, qualified, and validated, and you are equally comfortable arbitrating a hard engineering decision, defending a validation package to a client’s quality group, and holding a vendor or project team to schedule, scope, and margin. Because our equipment supports high-impact environments such as cleanrooms.

This is a builder’s role before it is a manager’s role. Germfree has established CQV, Field Service, and Certification teams as well as in-house design and build capabilities. This role will integrate all of these offerings into a comprehensive package tailored for our CGMP customers. Those teams and their leaders remain in place, continuing to own their own operations; the objective is to give them a stronger operating model, clearer standards, and the resources to take on larger and more complex GMP scope.

Key Responsibilities:

• Build Germfree’s internal GMP delivery capability: define the service lines, operating model, organizational design, rate structure, utilization targets, and the gating criteria for each phase of hiring.
• Own the overall strategy for delivery of CGMP systems, ensuring design, procurement, fabrication, installation, qualification, and turnover connect as one repeatable offering for regulated customers rather than as separate handoffs.
• Work closely with the CQV and Field Service groups, aligning strategy, standards, resourcing, and client commitments across the combined offering while each group continues to run its own operations.
• Establish Germfree’s approach to computer system validation and computer software assurance (CSV/CSA), providing a risk-based, critical-thinking framework for assuring GxP computerized systems consistent with current FDA guidance and GAMP 5 (Second Edition), in coordination with the CQV group.
• Provide governance for data integrity across validated systems, including 21 CFR Part 11 and EU GMP Annex 11 compliance, ALCOA+ principles, audit trail review, and electronic records and signatures.
• Select, qualify, and manage the third-party vendors that deliver automation, controls, and process engineering scope — owning technical specifications, bid evaluation, scope definition, deliverable acceptance, and ongoing performance management.
• Review and approve vendor design documents, software and control specifications, protocols, and turnover packages so that partnered scope integrates with Germfree’s qualification approach rather than running alongside it.
• Maintain an approved vendor list and a vendor qualification and audit program for GxP-impacting suppliers, in coordination with Quality.
• Serve as Germfree’s design authority for GMP facility and equipment scope, owning user requirement specifications, basis of design, design rationale, and formal design review gates.
• Set engineering and validation standards, deliverable templates, and review protocols in partnership with the CQV, Field Service, and Certification groups, so that quality is consistent and repeatable as project volume and complexity grow.
• Serve as the senior technical escalation on classification strategy, containment and air-handling concepts, material and personnel flow, utilities, and contamination control strategy.
• Help the Certification group build and scale certification services for CGMP customers — BSC, HEPA, cleanroom classification, VHP biodecontamination, and requalification — so the offering grows as a recurring, externally billable line rather than a project afterthought.
• Install disciplined project controls across the delivery portfolio: integrated schedule, cost and earned-value reporting, risk registers, and rigorous change management.
• Own change-order posture on self-performed scope — anticipate, price, and defend changes rather than absorb them.
• Integrate the procurement, expediting, and installation supervision bridge from purchase order through installation to CQV/IOQ, working with the shared corporate procurement function rather than duplicating it.
• Define which capabilities are held as core headcount and which are flexed as project surge or delivered by qualified partners, and manage that mix to protect utilization through demand swings.
• Own the function’s financial performance, including revenue, billable utilization, realized rate, gross margin, and contribution to EBITDA.
• Support sales and proposal efforts with credible scope, pricing, and staffing plans, and participate in client-facing pursuits and technical positioning.
• Work with the CQV, Field Service, and Certification groups to recruit and develop the phased team: design and process engineering, program management and controls, CQV and CSV engineers, and certification specialists.
• Build a technical career path, competency framework, and mentoring program that creates bench depth and advancement for the existing team as critical capabilities scale.
• Ensure all work conforms to cGMP requirements and applicable standards, including 21 CFR Parts 210/211, Part 11, and Part 820 as applicable, EU GMP Annexes 1 and 11, ISO 14644, NSF/ANSI 49, GAMP 5, and ISPE Baseline Guides.
• Partner with Quality, Legal, and Risk to extend the existing quality management system and professional liability posture to cover self-performed engineering, qualification, and validation scope.
• Serve as a senior client-facing representative of Germfree, clearly explaining technical positions, corrective actions, and recommendations to client stakeholders and regulators.

Required Knowledge and Skills:

• Deep, hands-on command of GMP facility, equipment, and process delivery, with a strong understanding of how design, procurement, installation, qualification, and validation connect as a whole.
• Deep working command of the full CQV lifecycle, from C&Q strategy through IQ/OQ/PQ and requalification, with deliverables that have withstood client quality or regulatory scrutiny.
• Working command of CSV and computer software assurance for GxP computerized systems, including risk-based validation strategy, Part 11 and Annex 11 requirements, and data integrity expectations.
• Proven ability to specify, select, and technically manage third-party engineering vendors — defining scope, evaluating proposals, reviewing deliverables, and holding suppliers accountable to standards and schedule.
• Working command of cGMP requirements and the governing standards and guidance for controlled environments.
• Direct experience with cleanroom, isolator, barrier, or containment systems, including biological safety cabinets, RABS, isolators, and HEPA-filtered environments.
• Proven ability to build a technical organization — operating model, standards, tooling, and staffing — not only to run one that already exists.
• Strong commercial judgment, with a clear understanding of where margin is created and lost in project delivery, and the discipline to manage to it.
• Excellent client-facing communication and interpersonal skills, with the credibility to represent Germfree to pharmaceutical, hospital, and institutional customers.
• Ability to influence across Sales, Product Engineering, Manufacturing, Quality, Procurement, and Finance without relying on direct authority.
• Comfort working in a high-impact, high-accountability environment where uptime, documentation quality, and schedule are critical.
• Self-starter capable of operating without existing infrastructure, creating process rather than inheriting it.
• Proficient in Microsoft Office applications (Outlook, Word, Excel, SharePoint, OneDrive) and familiar with project controls and validation lifecycle management platforms.

Qualifications:

• Bachelor’s degree in engineering (mechanical, chemical, biomedical, or industrial) or a related technical discipline required; an advanced technical degree or MBA is preferred.
• Minimum of 12 years of progressive experience in GMP facility, equipment, or process delivery within pharmaceutical, biotech, ATMP, medical device, or high-containment life-science environments.
• Minimum of 5 years leading multidisciplinary technical teams, including hiring, developing, and managing engineers and qualification staff.
• Demonstrated experience delivering CSV or CSA for GxP computerized systems — automation, control, laboratory, or quality systems — in a regulated environment.
• Demonstrated experience managing third-party automation, controls, or process engineering vendors on capital projects, including technical oversight and deliverable acceptance.
• Prior profit-and-loss or cost-center ownership, with accountability for utilization, margin, and budget.
• Experience standing up a new delivery, engineering, or validation function inside an established manufacturer is highly desirable.
• Hands-on background in field certification — NSF/ANSI 49, HEPA and BSC certification, cleanroom classification — and familiarity with accreditation requirements, is highly desirable.
• Experience with modular, mobile, or prefabricated GMP facility delivery is preferred.
• ATMP, cell and gene therapy, aseptic fill-finish, or hospital pharmacy compounding (USP <797>/<800>) experience is preferred.
• International project delivery experience, particularly in the Middle East or Asia-Pacific, is preferred.
• Professional credentials such as PE, PMP, CQE, CSQE, or ISPE/PDA certification are preferred.
• Valid driver’s license, an acceptable driving record, a valid passport, and the ability to travel up to 40% of the time.
• Employment is contingent upon successful completion of a background check and drug screening.

Physical Requirements and Working Conditions:

• Able to stand, walk, kneel, bend, and reach for extended periods, and to climb ladders and stairs during site walkdowns and inspections.
• Able to work on active construction sites, in mechanical rooms, and occasionally in confined or elevated spaces.
• Able to work in varying environmental conditions, including hot, cold, and noisy settings.
• Able to gown and wear required personal protective equipment (PPE) for cleanroom, laboratory, and pharmacy environments.
• Able to lift and carry up to 25 lbs, and occasionally more with assistance.
• Able to travel frequently, including driving, air travel, overnight stays, and international trips of extended duration.

Why You’ll Love Germfree: We want to make sure that you can expect excellence from us as well, and so we provide the best work environment possible to allow you to love what you do. As stated before, we will give you everything you need to succeed and will also motivate you to push yourself in new and positive ways. Whether this is meeting new people, working on projects you are passionate about, or innovating a process – we will help make it happen. A super hardcore work ethic, talent for building things, common sense & trustworthiness are required. At Germfree, you will get out exactly what you put in, and we know you can excel with us.

We are proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We value and celebrate the unique backgrounds, perspectives, and experiences of all individuals, and we believe that diversity drives innovation and growth. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.

We also maintain a drug-free workplace. Offers of employment may be contingent upon the successful completion of a drug screening, in accordance with applicable laws and company policies.