Validation Engineer

Location: Raleigh Consulting

Job Description

Job Description:
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 of control software and data retention related to the manufacturing processes for Injectables, Mixing Equipment, Clean Rooms, and Water for Injection systems.

Responsibilities:
• Responsible for ensuring FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation, and Data Integrity CFR21 part 11.
• This position will be implementing software driven systems while working with engineering and IT.
o AN extensive understanding of software systems and how to appropriately test is mandatory
o Must ensure computer systems and applications follow regulatory quality standards through validations activities.
o Must be able to understand and ideally assist with debug of applicable software while following the software life cycle procedures.
• Must perform process validation, process capability, and process control studies for assigned projects
• Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
o Will participate in and contribute to medium to large size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks.
o Partner with other support groups and manufacturing teams to complete work.
o Ability to function effectively as a member of a team.
o Will train others in the processes required for control software and data base validation.
• Responsible for ensuring the quality of facility systems validations:
o Writing and executing protocols and test cases for validations.
o Documenting/executing changes to applications.
o Assisting/leading training for systems.
o Develop test requirements and prepare and document test data for complex system testing.
o Audit trail data archives and queries correctly
o Experience with installation, administration, and validation of servers
o Provide support to resolve technical issues with systems under validation
• Ability to communicate effectively in written and verbal form.
• Must perform all other duties and responsibilities as determined by supervision/management.


QUALIFICATIONS:
• BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE) with at least 3 years of software focused validation experience.
• Soft Skills: Critical thinker, self-starter, team player, sense of urgency, engaged, solution oriented
o Ability to work with diversified cross functional team across different plant locations.
o Self-motivated and work well without direct supervision.
o Ability to quickly learn and understand applications.
• Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project,
• Familiar with Rockwell platforms such as Wonderware, Allen-Bradley PLC, and Factory Talk View
• Working knowledge process instrumentation in the pharmaceutical industry desired
• Candidates must meet visual acuity requirements as documented
• IQ / OQ / PQ & Data Integrity (ALCOA)
• 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.

Physical Requirements (Large manufacturing site)
• Requires continuous grasping, pushing/pulling up to 15 pounds and reaching with hands and arms.
• Lifting and carrying on average up to 15 pounds frequently throughout the shift.
• Normal visual acuity and the ability to distinguish color are necessary.
• Have the ability to complete quick and precise repetitive processes using both arms and both hands
• Occasionally specialized physicals are required when working with certain drug codes.
• Must be able to squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance
About Azzur
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.
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!
 


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