Life Science Facility Start-Up Resources

Go from empty walls to operational excellence—on time and on budget

Standing in an empty facility, it's hard to imagine the complex orchestration required to transform bare walls into a compliant, operational life science or medtech facility. Our facility start-up specialists have lived this transformation dozens of times. They bring the roadmaps, checklists, and hard-won experience that turns ambitious timelines into achieved milestones.

But here's what really matters: facility start-ups aren't just about equipment and procedures—they're about people and systems. Our start-up resources serve dual purposes. Yes, they manage the countless technical details of commissioning, qualification, and validation. But they also help you build the team that will run the facility long-term. They identify the skills you need, help evaluate candidates, and often become mentors to your permanent staff. Some even transition from start-up specialists to facility leadership roles themselves.

This bridge-to-hire approach is particularly powerful for facility start-ups. The person who builds your quality systems, validates your equipment, and trains your staff develops unmatched institutional knowledge. They understand every decision, every compromise, every strength of your facility. When the start-up phase transitions to routine operations, having that expertise in a permanent role provides invaluable continuity. Many of our most successful placements began as "temporary" start-up resources who proved too valuable to let go.

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Compressed timelines through parallel workstreams.

Our start-up specialists know how to sequence activities for maximum efficiency. They manage multiple workstreams simultaneously, preventing the costly delays that occur when critical path items are missed.

First-time-right facility qualification.

With experience across numerous start-ups, our resources anticipate and prevent the common pitfalls that cause validation failures. They ensure your facility passes regulatory muster on the first attempt.

Team building while delivering.

Our specialists help you evaluate and develop permanent staff while managing start-up activities. They transfer knowledge continuously, ensuring your team is ready when routine operations begin.

Seamless transition to steady state.

Whether transitioning to your permanent team or converting to a permanent role themselves, our start-up specialists ensure nothing falls through the cracks as you move from project to production mode.

Click to expand Facility start-up roles we support

QMS development roles that often bridge to permanent positions include, but are not limited to:

Facility Start-Up Director
Commissioning & Qualification Lead
Start-Up Quality Manager
Facility Validation Manager
Manufacturing Start-Up Lead
Cleanroom Qualification Specialist
Utilities Qualification Manager
Start-Up Project Director
Facility Systems Engineer
Environmental Monitoring Lead
Technology Transfer Manager
Start-Up Training Coordinator
Facility Compliance Manager
Operations Readiness Lead
Future Site Director (Bridge Role)

Is it time to augment your staff? When to engage facility start-up resources

Facility start-up resources are essential from the moment you sign a lease or break ground. Early engagement allows them to influence design decisions that impact compliance and operations. They're particularly valuable for companies launching their first facility, entering new modalities (like cell therapy), or managing multiple simultaneous start-ups.

The bridge-to-hire model excels here because facility start-ups naturally transition from project to operational phases. The specialist who commissions your cleanroom often becomes the ideal person to manage it. The quality lead who validates your processes may be perfect as your permanent Quality Director. This continuity reduces risk and accelerates your path to commercial operations.

Click to Expand A few frequently asked questions

What is staff augmentation—and how does it work?

Staff augmentation is a flexible workforce model where we provide full-time contracted professionals who work exclusively for your organization on a temporary basis. Unlike traditional consulting where advisors may serve multiple clients simultaneously, our staff augmentation consultants operate as specialized contractors that integrate directly into your team—following your processes, reporting to your management, and focusing solely on your priorities. This arrangement gives you immediate access to specialized expertise without the administrative burden, recruitment delays, and long-term commitment of permanent hiring.

Our staff augmentation process follows these key steps:

Needs Assessment: We begin with a detailed discussion of your requirements, including technical skills, experience level, project scope, timeline, and any specific certifications or backgrounds needed.
Resource Selection: Our recruitment team identifies candidates from our network of thousands of consultants, including hundreds of former FDA personnel, who match your specific requirements. We present only the most qualified candidates (typically 1-2) for your consideration.
Interviews and Selection: You interview the presented candidates and select the professional who best fits your needs. There's no obligation to proceed with any candidate who doesn't meet your expectations.
Onboarding: Once selected, the consultant is quickly onboarded to your organization. They become integrated into your team, using your systems and following your processes.
Management and Support: While you direct the day-to-day activities of the consultant, our account management team provides ongoing support to ensure your satisfaction throughout the engagement.
Flexibility: The engagement can be extended, scaled, or concluded based on your evolving needs, with no long-term commitment required.

What are the advantages of augmenting my staff?

Staff augmentation offers several key advantages for drug, device, biologic, biotech, and others in the FDA-regulated industries:

Immediate Access to Expertise: Gain specialized skills right away—without the 3-6+ month recruitment timeline typically required for quality roles.
Flexibility: Scale your team up or down based on workload fluctuations without the administrative burden of hiring and layoffs.
Cost Efficiency: Avoid expenses associated with permanent employees, including benefits, training costs, office space, and technology.
Risk Reduction: Test-drive your position's roles and responsibilities before committing to permanent hires, reducing the risk of misaligned job descriptions.
Knowledge Transfer: Benefit from best practices and specialized expertise that contracted professionals bring from their experience across multiple organizations.
Focus on Core Activities: Let your permanent team concentrate on strategic priorities while contracted resources handle specific projects or workload surges.

How do I know if staff augmentation is the optimal model?

Staff augmentation is typically ideal in the following scenarios—however there are many more than this:

Temporary Gaps: When you need to fill critical positions quickly during transitions, leaves of absence, or unexpected departures.
Project-Based Needs: When timelines don't justify permanent headcount, such as remediation activities, system implementations, or facility startups.
Specialized Expertise: When you require specialized skills that aren't needed continuously but are critical for specific phases or projects.
Headcount Restrictions: When budget constraints or hiring freezes prevent permanent additions despite workload demands.
Uncertain Duration: When the timeline for resource needs isn't clearly defined, making the flexibility of staff augmentation particularly valuable.
Skill Validation: When you want to validate job descriptions and responsibilities before committing to permanent hires.

If you're unsure whether staff augmentation is right for your situation, our account managers can help you evaluate your specific needs and recommend the most appropriate resourcing model. We do it all the time. Contact us.

What industries and therapeutic areas do you staff into?

We specialize in the FDA-regulated life science and medtech industries listed below. We also support Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and other service providers within these sectors. Our exclusive focus on FDA-regulated industries ensures that our consultants understand the unique regulatory requirements, quality standards, and compliance expectations specific to these sectors. This specialization allows us to provide resources who can contribute effectively from day one, without the learning curve typically associated with generalist staffing firms whose recruiters typically don't come from the industries they're hiring into.

Pharmaceuticals
- Rx (Prescription) Drugs
- Generic Drugs
- Combination Products
- Over-the-Counter (OTC) Medications
- Compounding Drug Products (including 503B facilities)
- Orphan Drugs (for rare diseases)
- Active Pharmaceutical Ingredients
- Radiopharmaceuticals
Medical Devices/Medtech
- Diagnostics
- Surgical Instruments
- Implantable Devices
- Wearable Medical Devices
- Dental Devices
- Ophthalmic Devices
- Orthopedic Devices
- Cardiovascular Devices
- Laboratory Developed Tests (LDTs)
- Software as a Medical Device (SaMD)
- In Vitro Diagnostic Devices (IVDs)
Biologics
- Biosimilars
- Vaccines
- Blood and Blood Components
- Allergenic Products
- Peptides
- CAR T-Cell Therapies
- Tissue-Engineered Products
- Monoclonal Antibodies
- Cell and Gene Therapy
- Stem Cell-Based Products
- Recombinant Therapeutic Proteins

What is the typical timeframe to bring on a staff augmentation resource?

Once your requirements are defined, we typically present qualified candidates within 3-5 business days—often much faster—sometimes virtually immediately. After selection, most consultants can begin within 1-2 weeks, depending on their availability and any onboarding requirements specific to your organization. For urgent needs, we can often accelerate this timeline, particularly for common quality roles.

What if the consultant or contractor isn't a good fit for our team?

While our 95% first-time success rate demonstrates our ability to match the right resource to your needs, we understand that not every placement works perfectly. If you're not satisfied with a consultant's performance or fit, we'll work promptly to address your concerns or provide a replacement under our Total Quality Guarantee. Our goal is your complete satisfaction with every placement.

What should I prepare for our initial discussion?

To make our initial conversation as productive as possible and help us identify the perfect resource for your needs, consider preparing the following information:

Role Description: A brief outline of the position you need to fill, including key responsibilities and deliverables. If you have a formal job description, that's helpful but not required.
Required Experience: Specific industry experience, technical skills, or regulatory knowledge the ideal candidate should possess.
Project Scope: For project-based needs, a summary of the project scope, key milestones, and expected timelines.
Timing Considerations: Your ideal start date and the expected duration of the engagement.
Location Requirements: Whether the role requires on-site presence (and where), can be performed remotely, or requires a hybrid approach.

Don't worry if you don't have all of this information prepared! Our account managers are skilled at asking the right questions to understand your needs. The more context you can provide initially, the more efficiently we can identify the ideal resource for your specific situation.

I'm interested—what's the first step I should take?

We make this very easy. The first step is simply to contact us for an initial conversation about your specific needs. Complete the form at the bottom of this page, and a dedicated account manager will reach out to you within one business day (often within hours) to discuss your requirements.

During this initial conversation, we'll discuss:

The specific role or expertise you're seeking
Your timeline and duration requirements
Technical skills and experience levels needed
Your budget considerations
Industry-specific requirements
Location preferences (on-site, remote, or hybrid)

After understanding your needs, we'll quickly identify suitable candidates from our network and present them for your consideration. There's no obligation to proceed, and we're happy to refine our search based on your feedback.

The entire process is designed to be simple and responsive, with our team handling all the details to connect you with the right quality professional as quickly as possible.

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Why work with The FDA Group?

Exclusive life science focus and expertise
Dedicated account management team
Right resource, first time (95% success)
97% client satisfaction
Total Quality Guarantee

Read our brochure »

Case Study QMS Remediation Through Staff Augmentation

The FDA Group helped a multinational pharmaceutical company eliminate its deviation and CAPA backlogs while implementing systemic quality improvements. Our team of 17 specialists tackled remediation activities, provided staff training, and ensured continuity of improvements across their QMS. The project was completed on time and under budget, restoring the company's compliance status without disrupting operations.

Read the case study (PDF) »

Case Study Long-Term Quality System Staff Augmentation

Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective staff augmentation model as a means of circumventing the administrative costs and burdens of traditional hiring.