job summary:
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.
location: Piscataway, New Jersey
job type: Permanent
salary: $90,000 - 120,000 per year
work hours: 9am to 5pm
education: Bachelors
responsibilities:
- 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
qualifications:
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.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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