Validation Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job title: Validation Engineer

Location: Marion, NC

Duration: 6+ Months

Job Description:

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.

• AN extensive understanding of software systems and how to appropriately test is mandatory

• Must ensure computer systems and applications follow regulatory quality standards through validations activities.

• Must be able to understand and ideally assist with debugging 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 processes/technology.

• Will 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.

• Ability to function effectively as a member of a team.

• Will train others in the processes required for control software and database validation.

• Responsible for ensuring the quality of facility systems validations:

• Writing and executing protocols and test cases for validations.

• Documenting/executing changes to applications.

• Assisting/leading training for systems.

• Develop test requirements and prepare and document test data for complex system testing.

• Audit trail data archives and queries correctly

• Experience with installation, administration, and validation of servers

• 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

• Ability to work with a diversified cross-functional team across different plant locations.

• Self-motivated and work well without direct supervision.

• 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.