Statement of Work
A defined scope with deliverables, acceptance criteria and a fixed price or capped budget. Peritus directs the work and carries delivery risk.
Pharmaceutical and mission critical engineering
Engineering and validation for pharmaceutical and mission critical facilities
Our core is pharmaceutical and biotechnology manufacturing: operational readiness, commissioning and qualification, validation and process engineering. We apply the same discipline to data centres, critical infrastructure and government programmes. A director leads every engagement and stays involved through to handover.
- Years of engineering leadership
- 25+
- Projects led by our directors
- 150+
- Client satisfaction on director led engagements
- 98%
- Industry sectors served
- 12+
Work aligned with
- Therapeutic Goods Administration GMP
- US FDA 21 CFR
- EU GMP Annex 1
- WHO GMP
- PIC/S
- ISO 13485
- ASTM E2500
- ISPE GAMP 5
About Peritus Consulting Partners
Pharmaceutical engineering at our core
Peritus Consulting Partners is a Sydney based engineering consultancy. Pharmaceutical and biotechnology manufacturing is our core. We also deliver commissioning and programme work for data centres, critical infrastructure and government. We take responsibility for a defined scope of work, a technical package or a full programme. We deliver it under our own technical direction.
Our directors each bring more than 20 years of experience across pharmaceutical manufacturing, engineering and managed services. They lead every engagement personally, supported by engineers who have built, started and validated facilities.
- Current engagements
- CSL, Seqirus, Pfizer and Zoetis
- Operating in
- Australia, with international capability and exposure
Services
Technical services across the manufacturing lifecycle
Operations
Operational readiness
Structured readiness programmes that prepare people, processes, systems and documentation for routine GMP operation from day one.
View serviceEngineeringProcess engineering
Process design, optimisation and scale up for aseptic fill finish, lyophilisation and biologics manufacturing.
View serviceQuality and complianceCommissioning and qualification
Risk based commissioning and qualification for filling lines, isolators, freeze dryers, sterilisation and clean utilities.
View serviceQuality and complianceProcess performance qualification and media fill
Strategy, protocols, execution support and recovery for process performance qualification and media fill campaigns.
View serviceQuality and complianceComputer system validation and data integrity
Validation of automation, laboratory and quality systems to ISPE GAMP 5 with ALCOA+ data integrity controls.
View serviceOperationsTechnology transfer
Structured transfer programmes for new product introductions, site transfers and scale up to commercial manufacturing.
View serviceDigital and AIDigital manufacturing
Manufacturing execution systems, control system integration, analytics and predictive maintenance.
View serviceOperationsOperational excellence
Measurable gains in equipment effectiveness, yield, cycle time and cost using Lean Six Sigma.
View serviceQuality and complianceRoot cause investigation
Deviation investigation, root cause analysis and corrective and preventive action for manufacturing issues.
View service
Industries
Expertise across life sciences and mission critical facilities
- Sterile fill finish
- Vaccines and plasma products
- Biologics and biotechnology
- Cell and gene therapy
- Solid dose manufacturing
- Active pharmaceutical ingredients
- Medical devices and diagnostics
- Animal health
- Contract manufacturing
- Data centres and mission critical facilities
- Government and public sector
How we engage
Four ways to engage us
Managed delivery team
A team of engineers assembled, mobilised and governed by Peritus, working as an extension of your engineering, quality and validation functions.
Embedded specialists
Senior engineers placed into your programme under Peritus technical oversight, with a clear path to move into managed delivery.
Specialist advisory
Senior practitioners engaged for design reviews, gap assessments, inspection readiness and decisions that need experienced technical judgement.
How an engagement runs
Scope
We agree the objectives, deliverables, acceptance criteria and risks with your project lead. We also confirm the commercial model.
Mobilise
We assemble the team, complete site inductions and set up governance, reporting and document control.
Deliver
We execute against the plan with milestone tracking, a live risk register and weekly reporting to your project lead.
Assure
We review every deliverable against your quality system and the agreed acceptance criteria before it is submitted.
Transition
We hand over documentation, knowledge and trained people so your site runs the system without us.
Why Peritus Consulting Partners
Why clients engage us
Directors who have done the job
Our technical director has spent more than 20 years inside sterile manufacturing and has built, started and validated facilities himself.
Work to every regulator you supply
We work to Therapeutic Goods Administration, United States Food and Drug Administration, European Medicines Agency and World Health Organization requirements.
Governance on every engagement
Each engagement has a milestone plan, a live risk register and weekly reporting to your project lead.
Working inside your team
We work on site, to your schedule, your quality system and your site procedures.
AI capabilities
Pharmaceutical expertise supported by our own AI tools
We combine deep manufacturing experience with AI and digital tools for predictive analytics, digital twins, investigation support and regulatory documentation, all designed for GMP regulated environments.
- 18%
- Batch yield improvement
- 42%
- Fewer deviations
- 35%
- Shorter regulatory approval time
- 22%
- Equipment effectiveness uplift
Average outcomes reported on AI assisted engagements led by our directors.
Explore AI capabilities
Case studies
Outcomes from engagements led by our directors
Operational readiness, Biopharmaceuticals
Large scale fill finish facility start up
A leading biopharmaceutical manufacturer needed full operational readiness support for a new aseptic vial filling line, including isolator integration, automation qualification and preparation for Therapeutic Goods Administration and US FDA inspection.
Read the case studyProcess performance qualification recovery, Sterile injectables
Qualification programme recovery after a failed campaign
A sterile injectable manufacturer experienced a failed process performance qualification campaign due to filling accuracy deviations and environmental monitoring excursions. The regulatory timeline was at risk.
Read the case studyCommissioning and qualification, Biopharmaceuticals
SKAN isolator qualification programme
A biopharmaceutical manufacturer required full qualification of a new SKAN isolator, including hydrogen peroxide decontamination cycle development, glove integrity testing and integration with the filling line.
Read the case studyLeadership
Led by industry practitioners
Our directors have delivered projects with
- Novartis
- CSL Behring
- Sandoz / Lek
- Lonza
- Merck
- SKAN
- IMA
- Belimed
- Bacthera AG
Discuss your project with an engineer
Tell us the scope, the site and the timing. A director will reply within one business day.