Job Description:
The Validation Engineer functions as the lead for all maintenance, engineering, and validation activities within the clinical packaging area. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent will be the primary liaison with the operations, engineering services, and third party vendors for executing activities within area of responsibility. The incumbent will also be responsible for the management of the area Engineering Technician. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations. Responsibilities
Manage all departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services.
Manage all equipment, facility, utility and cleaning validation activities.
Maintain the Validation Master Plan (VMP) as appropriate. Responsible for Validation Change Control documentation and managing the electronic tracking system.
Identify and implement opportunities to reduce costs, increase flexibility, and generate additional capacity through process improvement initiatives.
Interface with area managers from the Operations and Quality functions through the Validation Review Boards.
Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
Manage validation related, quality improvement projects to foster R&D compliance to regulatory, corporate and department requirements.
Represent department in quality audits, both internal and external, in regards to validation and engineering compliance.
Cultivate and foster strong working relationships with packaging operations and engineering validation disciplines.
Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
Supervise FTE engineering technicians and contract validation engineering as needed. Ensure employee resource allotment and workload requirements are balanced to meet the forecasted needs of the business.
Partners with all levels of key business functions to ensure packaging equipment has the functionality and is equipped to support new and ongoing clinical studies. Responsible for ensuring equipment reliability expectations are achieved in a high-throughput, clinical packaging facility.
Continually evaluates and balances short term production support needs with long term strategic objectives of the department.
Qualifications
Bachelor’s Degree, a BS in an engineering discipline.
5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area.
Knowledge/experience in creating and executing validation documents in VMS.
Knowledge/experience in Client engineering and financial systems.
General understanding of Client Engineering Standards and Specifications.
General understanding of pharmaceutical packaging equipment
Are you open to look at candidates who are willing to relocate? Yes
Years of experience/education and/or certifications required: 5+ years in pharmaceutical validation
What are the top 3–5 skills requirements should this person have
1. Skill/Requirement 1
Knowledge of equipment and facility validation requirements in pharmaceuticals
2. Skill/Requirement 2
Technical writing skills
3. Skill/Requirement 3
Self-starter
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Examples: Bachelor of Science; 4-year pharma, health care, or regulated industry
5+ years pharma experience with 2+ years of validation experience
What type of environment is this person working in?
Group setting
Individual Setting
Combination of both
Work Schedule (Define days, # of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?
Typical M-F with some opportunity for OT depending on workload
Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e., 1 day remote, 4 days on-site)?
100% On-site
Is the worker onshore or offshore?
Onshore
Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling:
No
Interview Process
Please define your required Interview Process (Phone or in-person interview)
Phone screen
Numbers & Facts
Location
Cincinnati, OH (Remote)
Salary
$51–$56.12 Per Hour
Skills
Biotech and Pharmaceuticalunmatched
Capital Projectunmatched
Change Controlunmatched
Change Requests/Ordersunmatched
Clinical Facilitiesunmatched
Clinical Trialunmatched
Cost Controlunmatched
Document Change Managementunmatched
Document Managementunmatched
Documentation Reviewunmatched
Engineering Managementunmatched
Equipment Validationunmatched
External Auditunmatched
Financial Systemsunmatched
Forecastingunmatched
Healthcareunmatched
High Throughputunmatched
Internal Auditunmatched
Offshoringunmatched
Operations Processesunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Production Supportunmatched
Project Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Requirements Validation/Verificationunmatched
Research & Development (R&D)unmatched
Schedule Developmentunmatched
Standard Operating Procedures (SOP)unmatched
Technical Writingunmatched
Time Managementunmatched
VMS Operating Systemunmatched
Validation Documentationunmatched
Validation Planunmatched
Willing to Travelunmatched
Work From Homeunmatched
Writing Skillsunmatched
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