Overview
On Site
Full Time
Skills
Regulatory Compliance
Acceptance Testing
HVAC
IQ
OQ
PQ
Organized
Quality Assurance
C
Life Sciences
Pharmaceutics
Manufacturing
GMP
Problem Solving
Conflict Resolution
Communication
Leadership
Management
Mentorship
Job Details
Responsibilities:
- Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements.
- Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance.
- Support the qualification of Black and Clean utilities, such as water systems, clean steam, HVAC, and gas utilities.
- Perform process equipment qualification to meet GMP and production readiness standards.
- Develop and execute C&Q protocols, including IQ, OQ, and PQ, in alignment with project requirements.
- Utilize Kneat software to manage, execute, and document qualification activities.
- Maintain detailed and organized records of all commissioning and qualification activities.
- Work closely with cross-functional teams, including engineering, validation, and quality assurance.
- Troubleshoot and resolve issues encountered during commissioning and qualification phases.
- Ensure all activities adhere to FDA, EMA, and other applicable regulatory guidelines.
- Identify opportunities to optimize processes and incorporate best practices into C&Q activities.
- Learning language lessons to improve efficiency and project outcomes.
- Bachelor's degree in engineering, Life Sciences, or a related field.
- Proven experience in commissioning and qualification in the pharmaceutical manufacturing industry.
- Expertise in Black and Clean utilities, process equipment, and FAT.
- Proficiency in Kneat software for C&Q activities.
- Strong understanding of GMP, FDA, and other regulatory requirements.
- Excellent problem-solving, organizational, and communication skills.
- Ability to work effectively in a fast-paced, team-oriented environment.
- Demonstrated leadership experience in managing complex projects or teams.
- Ability to mentor and guide mid-level engineers.
- Extensive experience in high-stake commissioning and qualification projects.
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