Department: Azzur of CA, LLC
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Work with Reliability Team to perform analyses of assets.
- Ensure adherence to specification.
- Develops Maintenance procedure encompassing proper preventive maintenance.
- Update existing and new Standard Operating Procedures to cover maintenance frequency of new and existing assets.
- Ensure that correct safety device is on the correct vessel.
- Spec out correct safety devices for the pressure vessel.
- Create maintenance procedures encompassing proper maintenance and care for pressure relief valves.
- Update existing SOPs to cover maintenance frequency and procedure of new and existing safety devices.
- Execute Reliability Centered Maintenance (RCM) or other improvement projects in assigned area.
- Support the implementation of predictive maintenance across the facility.
- May participate in FAT and commissioning of new or modified equipment.
- Identify cost/waste/energy reduction opportunities.
- May be assigned change control, Quality CAPA and Safety CAPA tasks.
- BS in Engineering, Science or equivalent technical degree.
- 2-5 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients through out the region.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.