UNIONIQ

Engineering & operational excellence consultancy

Process engineering for regulated manufacturing.

Principal-led design, qualification, functional safety and automation support for life sciences, food and beverage and the wider process industries — delivered as controlled, audit-ready documentation.

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WORKING TO IEC 61511 EU GMP EU GMP Annex 1 GAMP 5

01 / Why UNIONIQ

Senior engineering input, without large-consultancy overhead.

UNIONIQ is a principal-led consultancy. You get direct access to an experienced process engineer, a clearly defined scope, and documentation built to be reviewed and approved by your quality team.

Principal-led delivery

The engineer who scopes the work delivers it. No hand-offs and no dilution of expertise.

Audit-ready documentation

Every deliverable issued as a controlled document: numbered, versioned and approved.

Standards-first

Work aligned to IEC 61511, EU GMP and GAMP 5 from the first draft, not retrofitted at review.

Flexible engagement

Fixed-fee studies, day-rate support or full project delivery — scoped to what you need.

02 / Services

Four disciplines, one engineering standard

From concept design through qualification and safe operation — scoped, delivered and documented to GMP expectations.

01 — Process engineering

Process engineering design & optimisation

From early concept to detailed design, or improving plant that is already running — designs that are buildable, operable and ready for qualification.

  • PFDs and P&IDs
  • Mass and energy balances
  • Equipment sizing and specification
  • Debottlenecking and capacity studies
  • Process option assessments
Discuss your project
FIG. 01 — PROCESS FLOW DIAGRAM
FEED R-101 E-101 C-201 PRODUCT RECYCLE
02 — C&Q

Commissioning, qualification & validation

A risk-based, science-led approach to commissioning and qualification that avoids duplicated testing and stands up to inspection.

  • User requirements and design qualification
  • Risk assessments and traceability matrices
  • FAT and SAT support
  • IQ, OQ and PQ protocols and reports
  • Computerised system validation to GAMP 5
Discuss your project
FIG. 02 — QUALIFICATION V-MODEL
VERIFIES URS FS DS BUILD · FAT / SAT IQ OQ PQ SPECIFY VERIFY
03 — Functional safety

Functional safety to IEC 61511

Support across the safety lifecycle, so that safety instrumented systems are specified correctly, achieve their target SIL and stay compliant in operation.

  • Hazard and risk assessment support
  • Layer of protection analysis (LOPA)
  • SIL determination and verification
  • Safety requirements specifications
  • Proof-test and modification support
Discuss your project
FIG. 03 — LAYERS OF PROTECTION
EMERGENCY RESPONSE RELIEF DEVICES SAFETY INSTRUMENTED SYSTEM · SIL ALARMS & OPERATOR RESPONSE BASIC PROCESS CONTROL PROCESS DESIGN
04 — Robotics & AI

Robotics & AI-driven development

Practical automation for laboratories and production — robotic handling, machine vision and AI-assisted tools that speed up development and reduce manual error, designed with validation in mind from the start.

  • Robotic and automated handling concepts
  • Machine-vision inspection and guidance
  • Rapid prototyping of automated rigs
  • AI-assisted data analysis and process insight
  • Custom software and digital engineering tools
Discuss your project
FIG. 04 — VISION-GUIDED AUTOMATION
CAM-01 TRAY IMAGE AI MODEL MOTION COMMANDS

03 / Lifecycle

Support at every stage of the asset lifecycle

Engage for a single phase, or keep continuity from concept through to routine operation.

ServiceConceptDesignBuild & installCommissionQualifyOperate
Process engineering Core Core Supporting Supporting –Not typical Core
Commissioning, qualification & validation Supporting Core Core Core Core Supporting
Functional safety Core Core Supporting Core –Not typical Core
Robotics & AI-driven development Core Core Core Core Supporting Supporting

04 / Documentation

Audit-ready by default

Engineering work is only as good as the record it leaves behind. Every UNIONIQ deliverable is issued under GMP-style document control, ready for your QA review.

  • Unique document number, version and status on every page
  • Revision history and approval record
  • Traceability from requirements to test evidence
  • Issued on your templates and numbering, or ours

05 / Industries

Supporting the wider process industries

The same engineering disciplines apply wherever product quality, process safety and uptime matter.

Pharmaceutical & life sciences

GMP manufacturing, aseptic processing, utilities and facilities.

Biotechnology & bioprocess

Upstream and downstream processing, CIP/SIP and single-use systems.

Food & beverage

Hygienic design, batching, filling and production-line performance.

Water & wastewater

Treatment processes, purified water systems and site utilities.

Chemical & specialty process

Batch and continuous processing, hazard control and safety instrumented systems.

Energy & utilities

Steam, compressed air, thermal systems and other critical plant services.

06 / Approach

A controlled process, start to finish

  1. Scope

    Agree objectives, deliverables and a fixed-fee or day-rate basis before work starts.

  2. Assess

    Site visit, document and data review, and gap analysis against the applicable standard.

  3. Deliver

    Design, qualification protocols, safety studies or reviews, worked through with your team.

  4. Hand over

    Every deliverable issued as a controlled document, with version, date and approval status.

Ways to engage

FIXED SCOPE

Fixed-fee study

A defined deliverable at an agreed fee, such as a gap assessment or LOPA study.

Fixed fee, quoted per scope
FLEXIBLE

Day-rate support

On-site or remote engineering support to extend your team through a project phase.

Day rate on request
END TO END

Project delivery

Ownership of a complete design, C&Q, functional safety or automation package.

Quoted per project

07 / Principal-led

Led by a principal process engineer

Around 15 years of biochemical and process engineering across pharmaceutical, bioprocess, food and beverage, and water treatment, with specialist depth in functional safety and in aseptic process design and qualification. You work directly with the engineer responsible for the deliverable.

Process design Aseptic processing C&Q IEC 61511 SIL / LOPA GMP compliance Robotics & automation
~15 yrsBiochemical & Process Engineering
IEC 61511Functional safety, SIL and LOPA
GMPAseptic design and qualification

08 / Contact

Start with a scoping call

Tell us about the process, the problem and the timescale. We will come back with a proposed scope.

  1. Send a short brief using the form
  2. Scoping call to agree objectives
  3. Written proposal with scope and fee