POSITIONSUMMARY:
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 theCQV activities and fill finish processes in aGMP manufacturingenvironment.This position requires a strong understanding ofCQV andfill & finish processes and the ability to collaborate effectively with project teams. The ideal candidate willbe responsible forassistingin the creation of key documentation, ensuring project milestones are tracked, and providing hands-on support in cleanroom environments.
DUTIESANDRESPONSIBILITIES:
- Commission, qualify, andvalidatefacilities, utilities, and/or equipment in assigned projects.
- Assistsin authors, revises, reviews, and completes controlled documents for CQV projects.
- Assiststo review and qualify equipment for commissioning, qualification, and validation activities.
- Supportsto writeandreviewGMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Assisttoinitiateand 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 recipestartup, debugging, and documentation updates to align with process optimization efforts.
- Collaborate with client teams, vendors, contractors, and cross-functional stakeholders to deliver projectobjectives.
- Manage project activities, timelines, andstatus reporting while ensuring compliance with cGMP and data integrity requirements.
DEMONSTRATEDCOMPETENCIES:
- 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
REQUIREDEDUCATIONANDWORKEXPERIENCE:
- Bachelor's Degree in Engineeringor Life Sciences.
- Minimum3years of CQVand Fill Finishexperience within GMP-regulated environments.
- Hands-on experience with vial filling equipment and processes.
- Strong understanding of cGMP requirements, data integrity, andvalidationlifecycle principles.
- Excellent technical writing, communication, project management, and stakeholder engagement skills.
- Exposure to ancillary Fill Finish systems including isolators,depyrogenationtunnels, sterile filtration systems, and related aseptic processing equipment.
- Ability to manage multiple project priorities while working directly with client and site teams.