Description:
The Associate Process Engineer reports to the Technical Lead or head of Technical Services. Executes Process/Cleaning Validation/Study assignments as per directives. Creates protocols, data collection and analysis and prepare reports under supervision.

Essential Functions:
Prepare validation protocols & reports for manufacturing process and cleaning process qualification; data analysis and prepare reports; execute manufacturing process and cleaning process qualification/validation/study
Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements
Prepare and review manufacturing batch record and other engineering qualification documents as required
Coordinate/oversee the development of new processes or troubleshoot existing ones
Review Annual Product Review reports and plot trend analysis & APR reports
Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA)
Assist in various audits
Additional Responsibilities:
Performs other functions as required or assigned.
Complies with all company policies and standards.
Initiation of Change Controls and Planned Deviations when required
Reviews manufacturing/ Packaging batch records and Engineering qualification documents
Performs other functions as required or assigned.
Complies with all company policies and standards.
Education:
Bachelors Degree (BA/BS) Pharmaceutical/Chemical Engineering - Required
Master Degree (MS/MA) Pharmaceutical/Chemical Engineering - Preferred
Experience:
1 year or more in Pharmaceutical/Manufacturing Industry
Skills:
Excellent verbal and written communication skills. - Advanced
Proficiency in MS Word/Excel/Powerpoint. - Advanced
Multi-tasking. -
Specialized Knowledge:
Basic Analytical Knowledge desirable.
21 CFR, cGMP, basic manufacturing process knowledge.


Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity