Amneal Pharmaceuticals

Senior Manager, Process Engineering

Amneal Pharmaceuticals  •  Hyderabad, IN (Onsite)  •  3 hours ago
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Job Description

Ther role is accountable for leading the design, development, implementation, and optimization of pharmaceutical manufacturing processes to ensure efficient, economical, scalable, and compliant mass production. The role provides strategic direction across process design, equipment layout, scale-up, and validation activities while ensuring regulatory compliance and product quality. This position drives process robustness, risk management, and operational excellence across the product lifecycle. The role partners with Manufacturing, Quality, R&D, and Engineering teams to enable technology transfer, continuous improvement, and data-driven decision-making. The role also ensures audit readiness, performance optimization, and sustainable manufacturing practices aligned with business and regulatory expectations.


Essential Functions:

  • Lead process design, optimization, and manufacturing layout planning
  • Oversee process scale-up, technology transfer, and commercialization activities
  • Ensure regulatory compliance and GMP adherence across processes
  • Govern process validation strategies, IQ/OQ/PQ, and master plans
  • Drive deviation investigations, CAPA, and root cause analysis
  • Monitor process KPIs, yields, and performance metrics
  • Support equipment selection, installation, and automation integration
  • Lead risk management, FMEA, and safety assessments
  • Ensure quality, audit readiness, and inspection support
  • Mentor teams and enable training and competency development
  • Manage preventive maintenance of critical process equipments: RMG/FB/Fluid Bed Processor, Blenders, CAD Mill, Compression, Encapsulation, Auto‑coaters,
  • Vision/Checkweighers
  • Recommend vision systems and MES/eBR integration tools for process control
  • Support in investigations for blend uniformity, weight variation, lamination/capping, sticking/picking, dissolution failures, friability/coating defects
  • Approve equipment URS, FAT/SAT and support IQ/OQ/PQ from a process perspective



Additional Responsibilities: Education:

  • Bachelors Degree (BA/BS) B.E. - Required
  • Master Degree (MS/MA) ME - Preferred

Experience:

  • 15 years or more in 15+ Years

Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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 drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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