Validation Engineer II
The Validation Engineer II will work under the supervision of the Validation Manager and guidance from Lead Validation Engineers. This position provides technical knowledge and execution for new and renovated equipment, facilities, and utilities qualification to support commercial cGMP manufacturing and ensure compliance with internal and external policies and regulations.
Essential Areas of Responsibility
Provide execution support for equipment, facilities, and utilities qualification testing under approved protocols.
Author equipment, facilities, and utilities lifecycle documentation from approved templates in accordance with approved Standard Operating Procedures. Documents include risk assessments, test plans, qualification protocols, and reports.
Support equipment, facilities, and utilities requalification testing.
Own investigations and perform root cause analysis for minor deviations encountered during qualification.
Perform peer review on executed protocols.
Author and update Standard Operating Procedures (SOP's).
Adhere to site and global procedures and practices.
Adhere to applicable regulatory and industry guidelines and requirements.
BS in engineering or scientific field.
At least 4+years validation pharmaceutical industry experience, or 6+ years general commercial pharmaceutical industry experience.
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.
Systematically analyzes data and draws sound conclusions
Able to work independently once competency/training is established
Able to work as part of a team
Identifies solutions based on facts and data
Actively seeks direction when necessary
Counts self as accountable for the completion of assigned tasks
Contribute constructively within the department in an open an honest manner
Preferred Technical Knowledge/ Skills
Able to interact and coordinate with cross functional teams to execute validation tasks and in support of projects.
Able to gown into classified areas for sampling and validation execution.
Able to problem solve and apply critical thinking skills.
Excellent written and verbal communications, including technical writing. MS Office proficiency.
Experience with Trackwise, Veeva, SAP, Maximo, and Valgenesis is preferred.
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.