This position is with one of our direct clients in Marion, NC. Please submit resumes to pjhala at divihn dot com or call (630) 847 0267 with any questions. 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 a qualification in HVAC, Clean Room Qualifications, Compressed Air, and Water for Injection systems.
Must perform process validation, process capability, and process control studies for assigned areas
Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technology.
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.
Must ensure computer systems and applications follow regulatory quality standards through validations activities.
Responsible for creating the documents required for the development and validation of computerized systems.
Must be able to understand, test, and debug applicable software while following the software life cycle procedures.
Responsible for ensuring FDA regulations are met for system upgrades/replacements.
Responsible for ensuring the quality of facility systems (validation):
o Writing and executing protocols and test cases for validations.
o Coordinating testing and documentation of projects.
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 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.
This position will be implementing a software-driven system while working with engineering and IT.
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.
Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project (nice to have).
Wonderware, Allen-Bradley PLC, nice to have but not required
Experience with installation, administration, and maintenance of servers is helpful
Logical thought process.
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.
Quality Assurance or Pharmaceutical industry experience desired.
Candidates must meet visual acuity requirements as documented
The validation experience must focus on commissioning and qualifications.
IQ / OQ / PQ and Data Integrity (ALCOA)
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.
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 or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.