Lead Validation Engineer II
This is a lead level technical position within the Validation Department. The Lead Validation Engineer II will work under the supervision of the Validation Manager to provide technical leadership and accountability for qualification of equipment, facilities, and utilities, as well as validation of the associated process automation. The Lead Validation Engineer will also provide guidance and mentoring to the Validation Engineers on the team.
Lead equipment, facility, and utility qualification and process automation validation for clinical and commercial manufacturing and laboratory systems
Author, review, and approve validation documents for systems/projects of varying complexity from approved templates in accordance with approved Standard Operating Procedures. Documents include: Criticality Assessments, Risk Assessments, Design Qualification (DQ), Validation Master Plans, Test Plans, Test Protocols, Test Reports, etc.
Review change controls and assess their impact as well as define the required validation activities
Define validation strategy in alignment with company procedures and policies
Lead and participate within cross-functional teams to complete validation tasks and projects
Communicate proactively with team members, stakeholders, and management regarding progress, issues, and plans for resolution and to ensure the project team and/or network is fully informed of updates and improvements
Monitor/support on-going compliance and perform periodic system reviews ensuring that systems are maintained in a validated state
Ensure compliance with current validation policies and legislative requirements by setting and maintaining validation standards via validation SOPs
Support regulatory inspections and internal and partner audits, and implement corrective actions as needed. Provide validation related responses to inspectors/auditors
Execute validation test protocols for complex systems/projects.
Own investigations and perform root cause analysis for deviations encountered during qualification
Serve as a subject matter expert for equipment/facility/utility qualification at Wilmington site
Required Education and Experience
Bachelor’s degree in a scientific or engineering field
8+ years of relevant validation experience in a regulated environment (e.g. pharmaceutical manufacturing)
Able to manage multiple tasks in a fast-paced environment
Plans and prioritizes effectively according to task urgency and importance
Coordinates internal resources to complete validation tasks
Uses a risk-based approach to all aspects of validation
Must be computer literate and able to effectively use the MS Office suite of products
Experience with TrackWise, ValGenesis, Veeva, and Maximo is a plus
Experience working with Ellab wireless dataloggers and EvalPro monitoring systems is a plus
Systematically analyzes data and draws sound conclusions
Able to work independently once competency/training is established
Able to work as part of a team on a variety of complex and non-complex projects
Identifies solutions to both complex and non-complex problems based on facts and data
Actively seeks direction when necessary
Counts self as accountable for the completion of assigned tasks
Contributes constructively within the department in an open an honest manner
Excellent written and oral communicator
Demonstrates initiative and attention to detail
Approximately 70% office work, and 30% field execution work in manufacturing, utility, and laboratory spaces
Must be able to lift 25 pounds
Must be able to climb/descend ladders
Must be able to gown for entry into cleanrooms (Grade B, C, and D areas)
Routine travel is not expected but occasional travel may be required for training and testing (
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.