Commissioning and Qualification Specialist

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

We are seeking an experienced Full-time permanent
**Commissioning and Qualification Specialist**
- The position will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site. Actively participates during all phases of validation projects. Evaluates projects, provides technical information to others.
- Support the generation and execution of all commissioning and qualification documentation related to demonstration batches, thermal studies, validation studies for equipment, facilities, utilities, engineering test runs, development studies, software validation and final reports.
- Develop and Review of technical and quality system documents such as user requirements and specifications, SOPs, PLC, wiring diagram, FAT, SAT, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues. Ensure any document changes, meet quality and validation requirements and are in full compliance with regulations and standards.
- Manage and provide technical assistance and aid in resolution of punch-list / non-conformances / deviations.
- Recommendations to management as to the acceptance and release of qualified systems.

**Job Requirements**:

- Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
- Four (4) to seven (7) years of applied technical experience in the pharmaceutical or biotech industries.
- A strong combination of certifications and experience in directly related project/service experience with Industrial Process Control Systems, DeltaV, or other Distributed Control System (DCS) such as Rockwell and Honeywell.
- Hands on commissioning, qualification, and validation experience in at least two (2) of the following disciplines is preferred: Facilities (including design, flow analysis, HVAC), Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems), major equipment, process / cleaning and equipment validation / qualification or computer software validation.
- Firm understanding of cGMP validation requirements / guidelines and current industry practice.

**Why PharmEng Technology?**
Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

**What We Offer**:

- Comprehensive benefits package & competitive wages.
- A supportive environment where employee growth is promoted.
- Paid holidays.
- Other great incentives.

**EEOC Statement**
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.