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:

We are looking for a CQV/Fill Finish Engineer to join our team on a
12
-month contract
.
The CQV/Fill Finish Engineer will play an essential role in supporting the
CQV activities and fill finish processes in a
GMP manufacturing
environment.
This position requires a strong understanding of
CQV and
fill & finish processes and the ability to collaborate effectively with project teams. The ideal candidate will
be responsible for
assisting
in the creation of key documentation, ensuring project milestones are tracked, and providing hands-on support in cleanroom environments.

DU
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P
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:

• 
  Commission, qualify, and
  validate
  facilities, utilities, and/or equipment in assigned projects.
• 
  Assists
  in authors, revises, reviews, and completes controlled documents for CQV projects.
• 
  Assists
  to review and qualify equipment for commissioning, qualification, and validation activities.
• 
  Supports
  to write
  and
  review
  GMP and GDP documents and technical specifications.
• 
  Collaborate with multiple departments on assigned project activities and deliverables.
• 
  Assist
  to
  initiate
  and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
• 
  Ensure system integration with filling lines and compliance with validation requirements.
• 
  Support MES recipe
  startup
  , debugging, and documentation updates to align with process optimization efforts.
• 
  Collaborate with client teams, vendors, contractors, and cross-functional stakeholders to deliver project
  objectives.
• 
  Manage project activities, timelines, and
  status reporting while ensuring compliance with cGMP and data integrity requirements.

DEMO
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:

• 
  Business
  Development -
  Identify and
  target potential clients. Work in a team environment; develop and execute a
  plan, in alignment with company vision, mission and strategic plans to engage
  potential customers.
• 
  Relationship Building
  –
  Works with and across formal and informal professional and social networks to
  build long-term partnerships and connections in the life science industry and
  Internal team.
• 
  Negotiation Skills
  –
  Active listening, needs assessment, and presents visions to build a consensus.
• 
  Analytical Skills
  –
  Identifies, researches, and demonstrates logical reasoning to communicate
  critical information.
• 
  Rational Persuasion
  –
  Presents key factors, influencing factors, and strategic goals to assist
  stakeholders in identifying solutions.
• 
  Interpersonal Awareness
  – Ability to be aware of how actions, ideas, and communication
  can/does affect people and their outcomes.
• 
  Agility
  – Meets objectives by responding
  to competing and changing priorities and multiple tasks under inflexible
  timelines.

Requirements

R
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:

• 
  Bachelor's Degree in Engineering
  or Life Sciences.
• 
  Minimum
  3
  years of CQV
  and Fill Finish
  experience within GMP-regulated environments.
• 
  Hands-on experience with vial filling equipment and processes.
• 
  Strong understanding of cGMP requirements, data integrity, and
  validation
  lifecycle principles.
• 
  Excellent technical writing, communication, project management, and stakeholder engagement skills.
• 
  Exposure to ancillary Fill Finish systems including isolators,
  depyrogenation
  tunnels, sterile filtration systems, and related aseptic processing equipment.
• 
  Ability to manage multiple project priorities while working directly with client and site teams.