Process & Cleaning Validation Specialist, Technical Services

Merck & Co.; Piscataway Township (NJ); On-site; USD 80,000 - 90,000; Full time

Job summary

Merck & Co. seeks a Process Engineer to plan, execute and direct process/cleaning validation and studies with solid pharmaceutical engineering judgment. You will educate internal partners, monitor projects, and maintain cooperative relationships across departments.

Reporting to the Manager of Technical Services, you will manage post-approval projects, analyze data, and support deviations and audits while coordinating cross-functional teams to ensure timely completion of assignments.

Qualifications

• Bachelor's degree in Pharmaceutical/Biomedical Engineering required.
• Master's degree in Pharmaceutical/Biomedical Engineering preferred.
• 2+ years in Pharmaceutical/Manufacturing industry required.

Responsibilities

• Prepare validation protocols and reports for manufacturing process and cleaning process qualification; execute the qualification/validation/study.
• Coordinate with cross-functional teams to ensure timely completion of projects.
• Analyze statistical data, products or specs to ensure conformance with standards and quality requirements.
• Coordinate/oversee development of new processes or troubleshoot existing ones.
• Assist in deviation investigations to identify root causes and define corrective/preventive actions (CAPA) and assist in audits.
• Initiation of Change Controls and Planned Deviations when required.

Skills

Communication

MS Word

Excel

PowerPoint

MS Project

Education

Bachelor's degree (Pharmaceutical/Biomedical Engineering)

Master's degree (Pharmaceutical/Biomedical Engineering)

Tools

MS Word

Excel

PowerPoint

MS Project

Job description

Description:

Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.

Essential Functions:

• Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.


• Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.


• Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements


• Coordinate/oversee the development of new processes or troubleshoot existing ones


• Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits

Additional Responsibilities:

• Initiation of Change Controls and Planned Deviations when required

Education:

• Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required


• Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred

Experience:

• 2 years or more in Pharmaceutical/Manufacturing Industry

Skills:

• Excellent verbal and written communication skills - Advanced


• Proficiency in MS Word/Excel/ PowerPoint/MS project - Advanced

Specialized Knowledge:

• Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.

The base salary for this position ranges from $80,000 to $90,000 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.