What are the responsibilities and job description for the Commissioning and Qualification Engineers/Specialists (C&Q) position at PACIV?
PACIV, a global instrumentation, control systems integration, and regulatory compliance engineering firm with offices in Puerto Rico, the United States, the UK, and Ireland, servicing Biopharmaceutical, Medical Device, F&B, and Utilities clients, is looking for C&Q Engineers/Specialists in its Puerto Rico office.
Job Description:
The C&Q Engineer will be responsible for the development and execution of C&Q deliverables for Device Assembly and Packaging Manufacturing Equipment’s Systems Life Cycle (SLC) for new as well as legacy equipment/systems within the Biopharmaceutical/API and/or Medical Device regulated industries. The job role includes the determination of commissioning and qualification requirements for process, systems, and equipment in a secondary manufacturing facility. Provide support and coordinate the quality process over the life cycle of the projects assigned.
If you are interested in taking your technical knowledge and experience to the next level and creating, capturing, and sustaining value for yourself, please send us your CV.
Position Responsibilities/Essential Functions:
PACIV complies with all applicable federal, state, and local laws regarding non-discrimination and affirmative action. Employment is contingent upon successful completion of background checks and eligibility to work in the United States.
Job Description:
The C&Q Engineer will be responsible for the development and execution of C&Q deliverables for Device Assembly and Packaging Manufacturing Equipment’s Systems Life Cycle (SLC) for new as well as legacy equipment/systems within the Biopharmaceutical/API and/or Medical Device regulated industries. The job role includes the determination of commissioning and qualification requirements for process, systems, and equipment in a secondary manufacturing facility. Provide support and coordinate the quality process over the life cycle of the projects assigned.
If you are interested in taking your technical knowledge and experience to the next level and creating, capturing, and sustaining value for yourself, please send us your CV.
Position Responsibilities/Essential Functions:
- Determine, develop, and execute the C&Q deliverables for industrial equipment/systems within a secondary manufacturing facility.
- Support and coordinate the commissioning and qualification process
- Commissioning and Qualification (C&Q) deliverables will include the preparation of:
- Quality Project Plan
- System Impact Assessment
- Criticality & GMP Assessments
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Detailed understanding and experience with current regulations for Computer System Validation, such as FDA cGMPs for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk-Based Approach, ICH 9, ASTM E2500, and GAMP5.
- Familiarity and exposure to automatic device assembly and packaging systems in a bio-pharma environment would be advantageous.
- Education: Bachelor’s degree in engineering or related science studies.
- Minimum two (2) years related work experience with strong knowledge and hands-on experience of equipment/system commissioning, qualification (C&Q), and/or validation (CSV) in regulated industries.
- Currently working in device assembly and packaging processes with detailed knowledge of its associated technologies would be an advantage.
- Experience in the development and execution of C&Q deliverables for the system-development life cycle of bio-pharma equipment/systems.
- Experience with development and execution of DQ, Validation and Test Planning, Development and Execution (C&Q/CSV, Installation Commissioning (ICO) (ACO), Loop Checks, collate results and prepare Final Reports.
- Strong analytical and problem-solving skills.
- Deals well with uncertainty and pressure.
- Works well with others, within a team, and takes accountability.
- Result-driven and self-motivated.
- Strong interpersonal and communication skills (verbal and presentation).
- Organized, with strong computer literacy, such as MS Project, Excel.
- Competitive Salary
- Health Insurance
- Vision Insurance
- Life Insurance
- Complementary plans
- 401K
- Vacation and Sick days
- Trainings
PACIV complies with all applicable federal, state, and local laws regarding non-discrimination and affirmative action. Employment is contingent upon successful completion of background checks and eligibility to work in the United States.
