Description:
The Continuous Improvement Engineer is responsible for optimizing manufacturing processes, improving operational efficiency, reducing costs, and ensuring compliance with regulatory standards within pharmaceutical production environments. This role focuses on process improvement, capacity planning, workflow optimization, and implementation of lean manufacturing principles while maintaining strict adherence to Good Manufacturing Practices (GMP) and regulatory requirements.
Essential Functions:
- Lean Project Leadership and DMAIC Execution: Lead cross-functional teams through DMAIC roadmap to drive systemic process improvements. Utilize Value Stream Mapping (VSM) to identify and eliminate the 8 Wastes (DOWNTIME) in conjunction with Design for Manufacturing (DFM) and Design for Assembly (DFA) principles. Execute Kaizen events focused on Lean/Six Sigma methodologies, 5S, TPM, Visual Management and Standardized Work to achieve efficiency improvements while maintaining compliance with regulatory standards.
- Compliance, Validation & Regulatory Support: Ensure manufacturing processes comply with GMP requirements and regulatory authorities. Support equipment and process validation activities, including: Installation Qualification (IQ): Verify proper installation according to approved specifications. Operational Qualification (OQ): Confirm equipment operates within defined parameters. Performance Qualification (PQ): Ensure consistent performance under routine production conditions. Participate in protocol development, execution, documentation, audits, and change control activities. Support risk assessments and continuous compliance initiatives.
- Statistical Analysis and Data Reporting: Collect and analyze production and validation data to identify trends. Develop KPIs and performance dashboards to monitor process stability and capability indices (Cpk/Ppk). Apply statistical tools (Minitab) and data-driven insights to perform Root Cause Analysis (RCA) and trend validation.
- Cost Reduction & Continuous Improvement: Identify and execute cost reduction initiatives targeting scrap, rework, and deviations without compromising compliance. Translate operational wins into financial impact, focusing on annualized revenue increases and margin expansion.
- Conduct bottleneck analysis and line balancing to optimize throughput and manpower utilization. Perform production capacity analysis and forecasting.
Additional Responsibilities:
- Other duties as assigned.
Education:
- Bachelors Degree (BA/BS) Mechanical and Electrical Engineering Related field - Required
- Master Degree (MS/MA) Mechanical and Electrical Engineering Related field - Preferred
Experience:
- 3 years or more in Manufacturing, pharmaceuticals, engineering or related field
Specialized Knowledge:
- Must have strong computer skills, MS Office and MPR (SAP preferred).
- Previous Black Belt or Green Belt experience required
- Knowledge of cGMP, FDA and other regulatory compliance.
- Lean Six Sigma certification preferred
Computer aided design use (AutoCAD preferred)
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The base salary for this position ranges from $85,000 to $100,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
About UsAmneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected]. Requests will be handled confidentially and in accordance with applicable laws.
Skills Required
- Bachelor's degree in Mechanical or Electrical Engineering or related field
- Master's degree in Mechanical or Electrical Engineering or related field
- 3+ years experience in manufacturing, pharmaceuticals, engineering or related field
- Previous Black Belt or Green Belt experience
- Knowledge of cGMP, FDA and other regulatory compliance
- Experience with equipment/process validation (IQ/OQ/PQ) and change control
- Strong computer skills, Microsoft Office and MRP systems
- Experience with SAP
- Experience using statistical tools (Minitab) for RCA and capability analysis
- Experience with AutoCAD
- Lean Six Sigma methodologies (DMAIC, VSM, Kaizen, 5S, TPM)
- Successful completion of OSHA-compliant Respirator Fit Test
Amneal Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Amneal Pharmaceuticals and has not been reviewed or approved by Amneal Pharmaceuticals.
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Healthcare Strength — Medical coverage is presented as comprehensive with day-one eligibility for many U.S. roles, supported by wellness resources and transparency around plan information.
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Affordable Benefits — Employer contributions toward health coverage are described as generous, including periods where cost increases were absorbed and future employee contributions kept below broader trends.
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Retirement Support — A 401(k) plan with a company match and strong participation is positioned as a core element of the Total Rewards package.
Amneal Pharmaceuticals Insights
What We Do
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
