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Senior Pharmaceutical Process Expert; CMC​/Manufacturing Strategy

Job in Toronto, Ontario, M5A, Canada
Listing for: Chladni
Full Time position
Listed on 2026-02-23
Job specializations:
  • Pharmaceutical
    Pharmaceutical Manufacturing, Validation Engineer, Pharma Engineer
Job Description & How to Apply Below
Senior Pharmaceutical Process Expert (CMC/Manufacturing Strategy)
We are hiring a  Senior Process Engineer  with deep experience in  pharmaceutical manufacturing  to help us build the next generation of  process intelligence for GMP environments.

This role is not a traditional operations position. You will define  what data is realistically accessible inside pharmaceutical plants , how it should be interpreted, and how it can be used to deliver  accurate, compliant, and actionable insights —without disrupting validated systems.

You will play a key role in shaping a platform that learns  golden batch behavior , identifies process drift, and supports yield, quality, and energy optimization across pharmaceutical manufacturing.

What you will do

Define which process, equipment, batch, and quality data can be accessed in GMP pharmaceutical environments (without impacting validation or regulatory filings)

Translate pharmaceutical manufacturing reality into  robust process metrics  (golden batch, CPPs, CQAs, deviations, drift, variability)

Help design and validate ML-driven models that learn from historical and live batch data

Guide the development of physics-informed and data-driven approaches for batch comparison and process stability

Work closely with software and data teams to ensure models reflect real plant behavior, not theoretical assumptions

Ensure all system design aligns with GMP, data integrity, and regulatory expectations (FDA, EMA)

What we’re looking for

8+ years of experience in pharmaceutical manufacturing or biotech (drug product)

Strong background in  process development, MSAT, tech transfer, or GMP manufacturing

Deep understanding of batch processes, validation constraints, and change management

Experience working with manufacturing data (batch records, historians, process analytics, SPC, DoE)

Ability to bridge  process engineering and data/ML teams

Comfortable operating in regulated environments where compliance is non‑negotiable

Why this role matters
You will directly influence how pharmaceutical manufacturers safely adopt advanced analytics. Your expertise will define what "good" looks like for pharma process intelligence.

Seniority level
Mid‑Senior level

Employment type

Contract

Job function
Consulting and Strategy/Planning

Industries
Pharmaceutical Manufacturing and Business Consulting and Services

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Position Requirements
10+ Years work experience
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