Manager, Process Engineering (Manufacturing)

Description:

In this role, the Associate Manager will lead and support the installation and integration of Blow-Fill-Seal (BFS) systems, HVAC units, sterilizers, and other essential utilities, ensuring compliance with design specifications and operational standards. The Associate Manager will oversee technology transfer for the BFS platform to facilitate seamless adoption and manage validation processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Schedule:

1st Shift 8am-4:30pm Monday  to Friday

Essential Functions:

• Lead the design, development, implementation, optimization of the machinery, equipment, and utilities required for sterile BFS operations. Lead project management efforts for new equipment installation, facility upgrades, and process improvements, cost reduction, improved efficiencies, and enhancement of overall operational regulations.
• Lead the qualification and validation of sterile processes, ensuring compliance with FDA, ISO, and other regulatory standards. Prepare, review, and execute process validation protocols, reports, and SOPs.
• Monitor and document process performance and ensure compliance with internal and external regulations.
• Manage, guide, and mentor engineers and technicians, providing technical support and expertise in sterile process engineering. Foster a collaborative and efficient team environment, encouraging continuous learning and professional development.
• Identify and resolve process-related issues, providing technical support for production teams. Utilize data analysis tools to monitor process performance and recommend improvements. Conduct root cause analysis of deviations and implement corrective actions as needed.
• Collaborate with cross-functional teams to ensure successful process development and transfer to production. Provide technical expertise and guidance to other engineers, operators, and technicians. Develop and conduct training for production personnel on sterile process procedures and best practices.

 

Education:

• Bachelors Degree (BA/BS) Manufacturing, Engineering or related field - Required

Experience:

• 5 years or more in Engineering roles within a sterile manufacturing environment
• 2 years or more in Managing a team in a manufacturing or engineering function

Skills:

• Strong understanding of cGMP, FDA regulations, and other relevant standards. - Advanced
• Proven leadership and team management skills. - Intermediate
• Exceptional problem-solving and decision-making abilities - Advanced
• Strong communication and interpersonal skills to facilitate collaboration across teams. - Advanced
• Proficiency in relevant manufacturing and engineering software and tools. - Advanced

Specialized Knowledge:

• Excellent knowledge of FDA regulations in a pharmaceutical environment.

The base salary for this position ranges from $135,000 to $150,000 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.

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.