Validation Engineer II at Alkermes, Inc. in Wilmington, Ohio

Job Description:

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.

Required Qualifications

• BS in engineering or scientific field.


• At least 4+years validation pharmaceutical industry experience, or 6+ years general commercial pharmaceutical industry experience.

Preferred Competencies

• 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.

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Experience Level:
Associate

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