Accelerating time-to-market through Engineering
Under pressure,
Yet Still Slow
- Product lifecycles are becoming shorter, particularly in biopharmaceuticals and personalized therapies
- Late market entry leads to significantly lower revenue, while delays can result in permanent loss of market share.
- Typical project reality includes sequential phase-gate models, functional silos, and late handovers.
- Automation, IT, and qualification are brought in only after key design decisions have been made
- Regulation is not the problem. The issue is that regulatory requirements are often not integrated into early engineering decisions.
Where Time Is Lost and Why
The design freeze is either missing or is repeatedly relaxed—leading to cascading delays in procurement, construction, automation, and CQV
Scope creep caused by vague URS; missing batch logic and audit trail specifications lead to software change requests in the IBN
Treating CQV as a downstream phase creates validation bottlenecks; facilities are often completed before testing requirements are fully addressed.
Data integrity requires more detailed specifications, while long lead times for DCS and IT/OT infrastructure are often identified too late.
Disconnects between engineering, quality, IT, and operations; resource bottlenecks only become apparent when deadlines are looming. Decisions regarding skid- or stick-built construction are also made too late—making parallel production and pre-qualification with suppliers no longer possible.
SOPs, batch records, and training are often created only after mechanical or technical completion, delaying production start despite a qualified facility.
Early Decisions, Long-Term Impact
Early-phase decisions define the critical path. Corrections made later can trigger cascades of re-engineering, reorders, and repeated qualification activities.
Basic Engineering:
The Most Critical Phase
Capacity definitions, cleanroom zoning, automation architecture, and CQV strategy are established here. Early long-lead-item decisions enable parallel work packages and can save several months of overall project duration.
Design Freeze:
An Accelerator, Not a Constraint
Staged freeze concepts (parameter freeze, partial freeze, product freeze) allow early procurement starts for critical components. Projects without hard design-freeze milestones leave 10–20 % of acceleration potential untapped.
Modularization:
Skid or Stick-Built
Modular skid design or conventional stick-built plant? Because skids are pre-fabricated, pre-qualified and FAT-tested in parallel to building completion, and on-site work is reduced to connection and integration, this decision is one of the most effective early-phase levers.
Interface management:
The Critical Path
Integrated master schedules, early supplier involvement, and modular solutions significantly reduce interface risks. Digital tools make schedule risks visible early.
Key Levers of the EPCMV Approach
An integrated EPCMV approach connects Engineering, Procurement, Construction, Management, and Validation from the start, instead of treating them as sequential workstreams.
- Lever 01:
Integrated Project Execution Instead of Siloed Thinking
All relevant disciplines are aligned early. Interfaces are defined early to prevent friction later in execution. Handovers flow smoothly. Reference: 130 m², 1,300 pipelines, 18 skids — around 3 months saved through combined design phases. - Lever 02:
GMP and Validation Understanding from Day One: Validation-Ready Design as a Core Criterion
Compliance is designed into every project phase. Risk-based approaches focus effort on critical process and compliance points while reducing unnecessary qualification scope. - Lever 03:
Modularization and Standardization
GMP-compliant skids enable parallel fabrication, testing, and documentation while construction is still progressing. Reusable modules and standardized automation templates reduce engineering effort and improve schedule certainty. - Lever 04:
Digital Engineering Methods
End-to-end object models replace static, document-based engineering workflows. 3D coordination and clash detection resolve conflicts in the model before they reach the construction site.
Governance,
Partnership and
Decision-Making Culture
Even the best engineering concept loses impact without clear roles, short decision-making paths, and a partnership-oriented project mindset.
Clear Roles and Governance
Roles, responsibilities, and decision-making authority are established transparently at project kickoff. Decisions are made where expertise resides — not through formal escalation processes.
Production Start as the Guiding Objective
Every decision is evaluated by whether it accelerates or delays a qualified, stable production start, not simply by whether it satisfies a formal milestone.
Partnership Instead of a Supplier Model
Change management is built into the project structure. Changes are analyzed based on schedule, cost, and qualification impact, then decided jointly with the operator.
How to Identify the Right Engineering Partner
- Technical criteria
- Methodological criteria
- Organizational criteria
- Digital and regulatory competence
Technical criteria
- Demonstrable experience along the pharmaceutical value chain
- Deep understanding of the interfaces between process, facility, automation, and qualification
- Proven expertise in cleanroom concepts, batch processes, and Annex 1 requirements
- A strong track record on comparable projects by scope, complexity, and regulatory environment
- Ability to deliver right-first-time designs that minimize downstream adjustments
Methodical criteria
- Holistic project management rather than managing disciplines in isolation
- A clearly defined EPCM/EPCMV approach instead of stage-gate silo thinking
- Structured handling of design freeze, interface management, and change processes
- Modularization strategies and standardized concepts as deliberate tools for saving time
- Project approach explicitly oriented toward production start, not formal milestones
Organizational criteria
- Clearly defined roles, responsibilities, and decision-making authority
- Short decision paths instead of lengthy escalation loops
- Partnership-based collaboration as equals
- Willingness to take responsibility across disciplinary boundaries
- Established change management without jeopardizing the project schedule
Digital and regulatory competence
- End-to-end, data-based engineering methods instead of isolated documents
- Digital twins, simulations, and virtual tests for FAT/SAT
- Automation including MES, Historian, and PAT integrated from the start
- Design for compliance as a guiding principle across all project phases
- IT/OT convergence including cyber security and data integrity
Christian Peintner
Managing Partner
time-to-market is no accident
Short project durations are not the result of late acceleration measures, but the outcome of early, deliberate decisions in engineering and project organization.
SPIEGLTEC – we enable progress.
Many thanks to our clients and partners for all our successful projects!
