We are seeking a
Senior
Process Engineer
to support ongoing process development
within a
GMP
‑
regulated environment
. This role will play a key part
in
defining and managing process requirements for pharmaceutical projects, supporting system design, technology transfer, risk assessments, and compliance activities to ensure successful project execution and operational readiness.

Key Responsibilities

• 
  Provide technical leadership in the development and implementation of process technologies across capital projects, operational improvements, and manufacturing support activities.

• 
  Develop and
  maintain
  process design requirements, ensuring they are clearly defined, measurable, and aligned with project
  objectives
  and regulatory expectations.

• 
  Review and interpret process data, technology transfer packages, and manufacturing requirements to support equipment and system design decisions.

• 
  Partner with project, operations, quality, and engineering teams to ensure process solutions are effectively integrated into manufacturing environments.

• 
  Lead technical evaluations and risk-based assessments to
  identify
  process improvement opportunities and mitigate operational risks.

• 
  Support the design, commissioning, qualification, and validation of new and modified process systems to ensure they meet performance and compliance requirements.

• 
  Provide subject matter
  expertise
  during design reviews, troubleshooting activities, investigations, and process
  optimisation
  initiatives.

• 
  Ensure process changes are appropriately assessed, documented, and implemented through established quality and change management systems.

• 
  Facilitate risk assessments, FMEAs, and process hazard analyses to support project
  delivery.

• 
  Ensure compliance with quality, validation, engineering, and regulatory standards.

• 
  Partner with cross-functional teams to resolve technical issues and drive continuous improvement initiatives.

• 
  Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

• 
  Proficient in developing SOPs, final
  reports
  and validation & quality policies.

• 
  Strong experience developing and executing CQV protocols.

• 
  Strong experience creating and maintaining CQV policies and processes.

• 
  Has good understanding and complies
  to
  cGMPs
  and CFR21 Part 11 guidelines.

• 
  Exposure to
  digital and paper-based validation systems, including platforms such as
  Kneat
  .

• 
  Background in
  Pre-filled
  syringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product, New Product Initiative (NPI) manufacturing, Plasma Manufacturing