Azzur personnel are expected to always live up to our core values 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.
This position is responsible for.
- Performing and reviewing computerized system validation deliverables according to 21CFR Part 11, Annex 11, GAMP 5 and other regulatory requirements.
- CSV for stand-alone systems and will be "bolting" on software components and integrating software into other larger systems.
- Generate and/or review validation documentation - such as user requirements, functional requirements, configuration specification, Validation Master Plan (VMP), IQ/OQ/PQ documentation, GxP criticality assessments, Electronic Records Electronic Signature (ERES) assessments, Data Integrity (DI) assessments, test scripts, trace matrix requirements, deviations, validation summary reports, and system use documentation (system admin, user admin procedures).
- Author and develop SOPs for computer system validation for manufacturing and QC Lab equipment.
- Responsible for executing and reviewing control systems validation activities including projects associated with PCS, BMS, EMS, OSI PI, and other automation upgrades.
- Collaborate with equipment vendors for Windows upgrades and perform CSV activities necessary for the QC Lab equipment/system.
- Ensure that a consistent computerized system validation approach is utilized for IT infrastructure, Computerized Process Equipment, Manufacturing Computerized Systems, and QC Lab Systems.
Qualification and Requirements:
- Bachelors or Masters in engineering, science, or equivalent technical degree.
- 3-5 years of experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
- 3+ years of project experience with Computer systems validation experience with or for manufacturing equipment and processes, as well as utilities, and facilities. Experience with Validation lifecycle documentation (URS, FS, DS, ERES Assessment, DI Assessment, IQ, OQ, etc.)
- Experience with Quality Systems (handling Change Controls, Non-Conformances, Deviations, CAPAs)
- Expertise in CSV for custom built and/or off the shelf equipment.
- Experience in GAMP-5 category 3, 4, and 5 equipment computer system validation
- Good knowledge and skills in engineering of HVAC/Cleanrooms/Process Equipment and Utility/Building Management Systems
- GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211 requirements, Data Integrity, ICH Q7A requirements, and GAMP 5
- 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.