Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.Summary:
Provide hands on validation support to several facility/utility and equipment qualifications that are planned for the site. This validation engineer will need to have experience with qualification in HVAC, Clean Room Qualifications, Control Rooms and filtration systems as well as familiarity with Computer System Validation and Control Systems (NOT programming level). Prior experience within a Pharmaceutical or Medical Device environment is required (GxP experience).
- Responsible for creating documents required for the Qualification / Validation of Facilities, Utilities, Equipment and computerized systems. IQ/OQ/PQ and Data Integrity (ALCOA) required.
- Must perform process validation, process capability, and process control studies for assigned areas
- Must participate in and contribute to medium to large size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks.
- Partner with other support groups and manufacturing teams to complete work.
- Responsible for ensuring FDA regulations are met for system upgrades/replacements.
- Responsible for ensuring the quality of facility Qualification and Validation packages
- Provide support to resolve technical issues with systems under validation
- Ability to function effectively as a member of a team.
- Ability to communicate effectively in written and verbal form.
- Must perform all other duties and responsibilities as determined by supervision/management.
- The basic understanding of software systems and how to appropriately test is mandatory.
- BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE) with at least 3-5+ years of experience.
- IQ / OQ / PQ & Data Integrity (ALCOA) experience / knowledge
- Must have pharmaceutical or medical device experience
- Soft Skills: Critical thinker, self-starter, team player, sense of urgency, engaged, solution oriented
- It will be important for the individual to be able to work days, nights, holidays, and/or weekends as needed by the project timeline to meet manufacturing deadlines.
- Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project (nice to have).
- Wonderware, Allen-Bradley PLC, nice to haves but not required
- Experience with installation, administration, and maintenance of servers is helpful
- Leadership skills.
- Logical thought process.
- Ability to work with diversified cross functional team across different plant locations.
- Self-motivated and work well without direct supervision.
- Ability to quickly learn and understand applications.
- Quality Assurance or Pharmaceutical industry experience required.
- Candidates must meet visual acuity requirements as documented
- Validation experience must focus around commissioning and qualifications.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!