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Sr. Validation Engineer Job in Wilmington, Ohio US

Sr. Validation Engineer

Alkermes, Inc. - Wilmington, OH

Posted: 8/9/2022 - Expires: 11/7/2022

Job ID: 245562924

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Job Description

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global  biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Senior Validation Engineer

Summary

Responsible for the application of technical ability, expertise and specialist knowledge in process validation, cleaning validation and equipment /facility to site qualification program needs. Write, review and approves equipment and process lifecycle documentation. Develop and implement site policy and procedures on cleaning /process /equipment / facility in line with Quality Risk Management principles. Liaise with and present to regulatory bodies and associated agencies as required. Key oversight and validation execution on continuous improvement initiatives and critical site projects.

 

Essential Functions

Serve as a subject matter expert and system owner for Validation at Wilmington site.  Responsible to conduct routine regulatory surveillance, conduct gap assessment against Alkermes' policies and standards - 30%

Lead validation projects deemed critical for Alkermes - 30%

Ensures KPIs are linked to organizational vision and uses KPIs to alter approach in meeting validation objectives - 20%

Gap assess and improve site procedures and processes/templates - 20%

 

Required Education and Experience

Bachelor's degree in engineering, pharmaceutical science, or related field required

8+ years of industry experience in Quality role and/or pharmaceutical validation required

 

Preferred Education and Experience

Master's degree in engineering, pharmaceutical science, or related field required

Experience using Valgenesis, Trackwise, and/ or Veeva.

2+ years of team leadership or management experience

 

Preferred Competencies

Distinguishes between critical and non-critical team conflicts, anticipates issues, and resolves through consensus where appropriate. Listens and responds to varying needs in logical and articulate manner to gain acceptance of an idea or plan

Challenges current methods and practices offering new ideas and solutions to enhance performance

Applied knowledge of cGMP regulations and guidelines.  Practical knowledge of ASTM E2500 for specification, design, and verification of manufacturing systems

Uses effective communication to influence stakeholders/audience by tailoring messages appropriately for internal and external audiences

Able to coordinate multiple complex tasks at once and re-prioritize, as required, to achieve department and site goals

 

Work Environment

Office environment with less than 10% of time in production areas supporting assessments, troubleshooting and qualification work. Clean room gowning in class C/D areas will be required. Partial work from home is available for this position once training is up to date.

 

Travel

Some travel (~10%) may be required for business purposes

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:
Mid-Senior Level

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.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
64824237_2
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A