Process Engineer - Stoughton (1139)

Since 1961 Colorcon has played a vital role in the advancement of film coating technology and solid oral dose development for pharmaceuticals. Our current reputation as the "Supplier of Choice" is based on the superior product quality, unparalleled technical support, and extensive regulatory assistance. Today we are proud to have over 25 locations worldwide, including 18 technical service laboratories, 8 manufacturing facilities and over 1,200 talented individuals - our valued employees. Along with being the "Supplier of Choice" Colorcon is the "Employer of Choice." To learn more about Colorcon and our exceptional culture and benefits package visit our website at http://www.colorcon.com Description



The Site Process Engineer insures that Colorcon's products will consistently meet the expectations of our customers.  This is achieved by developing a deep understanding of current process technologies, product specifications, product applications and their interrelationships.  The Process Engineer works collaboratively with associates from Operations, Quality Control, Maintenance, Logistics, Global Engineering, and New Product Development to maintain and improve the integrity of existing processes and to develop new processes that result in even greater product quality, consistency and lower cost. The position is located in Stoughton, WI and reports to the Site Manager. Maintains confidentiality of sensitive information including, formulas, processes, and designs unique to projects and products in development.


Responsibilities & Duties Develops an in-depth understanding of manufacturing processes, equipment specifications, product specifications, product applications and their interrelationships at the Stoughton facility. Leads multi-disciplinary teams and interacts closely with Manufacturing, Quality Control, Maintenance and Global Engineering on improvements or future product line extensions. Uses critical thinking, analytical and problem solving skills to move projects forward and give future direction. Understands and adheres to current good manufacturing practices (cGMP), good laboratory practices (GLP), good documentation practices (GDP), safety guidelines and accurate documentation of experiments and activities. Presents technical summaries in various forms including detailed written reports and oral presentation. Prepares documentation and procedures associated with equipment specifications, manufacturing processes and procedures.  Responsible for process optimization from identification, concept, implementation, documentation and operator training. Writes and performs validation IQ/OQ/PQ protocols and reports to meet cGMP regulations.  Responsible to ensure harmonization of processes and equipment for plant manufacturing and global standardization. Evaluates current / future product line processes for optimization. Manages project budgets, timelines, establishes work priorities, and evaluates cost and time requirements. Requisitions equipment, components and supplies for process engineering projects, interacting with vendors to obtain price and product information.Required Experience

Requires a B.S. in Engineering or Chemistry.5 years experience in Process Engineering, 5-10 years experience in Pharmaceutical or Food Manufacturing desired.Requires strong trouble shooting experience, qualification and validation Experience.Documentation experience including P&IDs, Blue Prints, Schematics.  Self starter with strong communication and interpersonal skills.Ability to work independently or as a team member.Proficient with Microsoft Applications and the internet.Dry Powder, Automation, Lean Manufacturing, ISO 9000 and Auto Cad experience a plus.In order to make sure that Colorcon receives all of your information we require that everyone complete our online application at http://www.colorcon.com Please click on this link to be directed to our application: http://hostedjobs.openhire.com/epostings/jobs/submit.cfm?fuseaction=dspjob&jobid=240614&company_id=15621&jobboardid=24Colorcon is an Equal Opportunity Employer (EOE M/F/D/V)