Lead Computer Systems Validation Engineer I (Clinical & R&D)

• Bachelor’s degree in computer science, Life Sciences, Engineering, or related field, with 9+ years of progressive experience in Digital Quality within a GxP-regulated pharmaceutical or biotech environment (master’s degree with 7+ years also considered)
• Highly Quality minded with experience supporting computer system validation activities in a GxP-regulated environment is preferred. Strong quality systems, compliance, and data integrity experience is required, including experience with Enterprise Quality Systems (e.g., LMS, Veeva DMS, TrackWise/TrackWise Digital) and paperless validation platforms such as ValGenesis
• Knowledge of GxP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, Part 312, Part 314, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10
• Excellent interpersonal, leadership, collaborative, communication (written and verbal), and time-management skills are essential
• Proven track record in current and previous roles. Results and Performance driven
• Strong leadership skills and ability to work within cross-functional teams.

leading teams is essential

• Flexibility and adaptability to changing needs and requirements

The annual base salary for this position ranges from $110,000 to $126,000.

In addition, this position is eligible for an annual performance pay bonus.

Exact compensation may vary based on skills, training, knowledge, and experience.

Alkermes offers a competitive benefits package.

Additional details can be found on our careers website: www.alkermes.com/careers#working-here

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home.

This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week.

This role is not eligible for fully remote work.

#LI-AH1

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders.

A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases.

We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations.

In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.