Deskripsi Pekerjaan
Job Title: Commissioning & Qualification (CQ) Engineer – Pharma / Medical Device
Location: West Region
Salary: $5,000 – $7,500 per month
Our client, a respected leader in the pharmaceutical and medical device industry, is seeking a skilled Commissioning & Qualification (CQ) Engineer to join their team. This is a fantastic opportunity for an experienced engineer to play a key role in ensuring the highest standards of quality and regulatory compliance across critical projects.
As a CQ Engineer, you will plan, execute, and document commissioning and qualification activities for equipment, utilities, and facilities. Working closely with project teams, you will ensure systems are designed, installed, and operate in line with cGMP, FDA, and EU requirements. Your expertise will directly contribute to the successful delivery of manufacturing capabilities.
Key duties include developing IQ/OQ/PQ protocols, leading FAT/SAT activities, managing deviations, change controls, and supporting regulatory inspections. The ideal candidate brings a solid engineering background, deep knowledge of validation practices, and a proactive approach to problem-solving. If you are passionate about quality and thrive in a collaborative environment, this role offers excellent career growth and the chance to work with cutting-edge technologies.
Tanggung Jawab
- Develop and execute commissioning and qualification protocols (IQ, OQ, PQ) for equipment, utilities, and facilities.
- Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
- Ensure all qualification activities comply with cGMP, FDA, and EU regulatory requirements.
- Manage deviations, change controls, and non-conformances during qualification.
- Prepare and review technical documentation, including validation reports and SOPs.
- Collaborate with cross-functional teams (Engineering, Quality, Production) to meet project milestones.
- Support regulatory inspections and audits by providing documentation and subject matter expertise.
- Continuously improve qualification processes and methodologies.
Kualifikasi
- Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related field).
- Minimum 3–5 years of experience in commissioning and qualification within pharmaceutical, medical device, or biotechnology industries.
- Strong knowledge of GMP, FDA, and EU regulations.
- Experience with risk-based qualification approaches (e.g., ASTM E2500).
- Proven ability to write and execute protocols and reports.
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills for team collaboration.
- Professional certifications (e.g., CQE, CSQE) are a plus.