Manufacturing Systems Specialist
Millipore Corporation

Job Info

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Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEMM Indianapolis Manufacturing Systems
Recruiter: Katherine Hall

Hiring Manager: Nikhil Sabu
This information is for internals only. Please do not share outside of the organization.

Your Role:

The Manufacturing Systems Specialist plays a critical role in ensuring the efficient and compliant operation of manufacturing systems within the pharmaceutical/biotech industry.

Responsibilities include but are not limited to:

• Collecting and analyzing data to identify trends, performance metrics, and areas for improvement within the manufacturing systems.
• Reviewing batch records to support product release, ensuring accuracy, compliance, and adherence to quality standards.
• Investigating and writing deviations, ensuring thorough documentation and timely resolution to maintain product quality and compliance.
• Completing Corrective and Preventive Action (CAPA) projects and other Continuous Improvement (CI) projects as assigned, driving process enhancements and operational excellence.
• Controlling the incoming and outgoing documentation to the manufacturing department, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Providing support to leadership during audits, including preparation, documentation review, and response to audit findings.
• Completing SAP transactions and reconciling materials and products in a timely and accurate manner, ensuring inventory accuracy and compliance with regulatory standards.

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Biotechnology, Chemical Engineering, or other Life Science discipline.
• 3+ years of experience in a pharmaceutical or biotech company.

Preferred Qualifications:

• Experience in data analysis, batch record review, deviation investigation, and CAPA project management.
• Experience in controlling documentation, supporting audits, and completing SAP transactions.
• Lean Six Sigma Green Belt certification.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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