Temp-Validation Engineer

Alkermes • Wilmington, OH

1d

About The Position

Validation Contractor/Temp
Provide execution support for equipment/facilities/utilities validation and requalification testing.
Author validation summary reports and protocols.
Author deviations and provide investigation support.
Perform peer review on executed protocols.
Adhere to site and global procedures and practices.
Adhere to applicable regulatory and industry guidelines and requirements.
Qualifications
Minimum education and experience requirements
BS in engineering or scientific field.
At least 3+ years validation pharmaceutical industry experience, or 6+ years general commercial pharmaceutical industry experience.
Preferred Technical Knowledge/ Skills
Able to interact and coordinate with cross functional teams to execute actions for validation studies and in support of projects.
Able to gown into classified areas for validation execution.
Experience in sterile and oral solid dosage pharmaceutical processes a plus.
Able to problem solve and apply critical thinking skills.
Excellent written and verbal communications, including technical writing. MS Office proficiency.
Positive attitude
Work Environment
Work will be split between manufacturing areas and office
Must be able to lift and operate test equipment.
Must be able to gown into classified areas.

Why join Team Alkermes?
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.

Requirements

• BS in engineering or scientific field.
• At least 3+ years validation pharmaceutical industry experience, or 6+ years general commercial pharmaceutical industry experience.
• Able to interact and coordinate with cross functional teams to execute actions for validation studies and in support of projects.
• Able to gown into classified areas for validation execution.
• Able to problem solve and apply critical thinking skills.
• Excellent written and verbal communications, including technical writing.
• MS Office proficiency.
• Positive attitude
• Must be able to lift and operate test equipment.
• Must be able to gown into classified areas.

Nice To Haves

• Experience in sterile and oral solid dosage pharmaceutical processes a plus.

Responsibilities

• Provide execution support for equipment/facilities/utilities validation and requalification testing.
• Author validation summary reports and protocols.
• Author deviations and provide investigation support.
• Perform peer review on executed protocols.
• Adhere to site and global procedures and practices.
• Adhere to applicable regulatory and industry guidelines and requirements.

What This Job Offers

• Career Level: Mid Level