Actavis Inc. is the U.S. subsidiary of Actavis Group, a global leader in developing, manufacturing and marketing high-quality generic medications with more than $2.25 billion in worldwide sales in 2010. Approximately one-third of all sales are generated in the United States, Actavis’ largest single market and home to seven locations: three in New Jersey, two in Florida and one each in Maryland and North Carolina.
The process engineer will be responsible for developing and optimizing processes that will be utilized in the manufacture of immediate and extended release dosage forms at Actavis. The engineer will have a key role in the technical transfers of processes to internal (i.e. within Actavis divisions) and external development sites. The engineer will design and conduct development studies to define critical operating parameters of unit operations employed in the manufacturing process at the lab and pilot scales to assure resultant product possess repeatable characteristics.
The engineer will be responsible for generating required documentation for the execution of development, and cGMP scale batches to capture process observations and data to advance the development projects and meet project milestones. Documentation will include but not limited to master batch records, study protocols, development/technical reports, deviations, change controls, standard operating procedures, etc.
Provides process development and optimization support for new products, both internal development and external contract manufacturing facilities
Leads confirmation and exhibit batch manufacturing of new products, including alternate API source
Leads scale up and technical transfer activities in both pilot and commercial (internal and external) scales
Provides technical support in the manufacturing of validation batches. Also, provides technical input for trouble shooting of internal and external commercial manufacturing issues
Develops documents such as exhibit and commercial master formulas, protocols, reports, QOS and other documents required for ANDA submission
Supports the pilot plant and new product development facilities with respect to standard operating procedures, cleaning verification protocols/reports, environmental/safety initiatives, new equipment procurement and commissioning, etc.
Initiates and completes deviation investigations, corrective action/preventive action (CAPA) items, change controls, etc.
Acts as interface between formulation development and technical services
Identifies and implements process improvement opportunities for commercial products
BS/MS in Chemical Engineering, Engineering, Pharmacy, Chemistry or equivalent with minimum 2 years of pharmaceutical industry experience in process development, technical services, and/or manufacturing.
Solid understanding of unit operations and critical process parameters used in the manufacturing of pharmaceutical dosage forms including controlled release drug delivery systems
Ability to structure and execute efficient experimental designs to develop and optimize manufacturing processes
Thorough knowledge of Good Manufacturing Practices
Knowledge of FDA regulatory guidance’s, ICH guidelines and requirements of ANDA submissions
Working knowledge of Microsoft suite of software products including Excel, Word and PowerPoint
Strong oral and written communication skills
Strong organizational skills with the ability to multi-task and prioritize assignments
Ability and willingness to work in a cross-functional team environment
Self motivated with the ability to work independently with minimal supervision
Ability to work under pressure to meet short-term deadlines
Able to travel as needed
Actavis is a values-driven organization that encourages and rewards ambition, creativity and accountability; and is active in local communities. Actavis is an Equal Opportunity Employer and offers an attractive compensation and benefits package to support its goal of being an employer of choice in the industry.
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