Process Development and Technical Services Manager

Reports to: V. P. Product Development 

 

Supervises: Jr. Processing Engineer

  Processing Engineer

 R&D Lab/Clerical Assistant (Shared between R&D Director)  

 Process Development

·  Plan and schedule all pilot batches and line trials and communicate consistently with manufacturing, planning and sales on this schedule and when needed, the customer.

·  Direct all related activities on pilot batches and line trials and arrange for all needed chemical, equipment, and support personnel.  This is to be coordinated through manufacturing, planning and operation management.

·  Responsible for all related reports, documentation, and follow up activities pertaining to all pilot batches and line trials.

·  Direct Master Formula writing and implementation including manufacturing and filling procedures, initial product specs, and related documentation.

·  Direct the activities (either direct report or in conjunction with the Director of R & D) of the batch card clerk and issuance of batch cards using the formula documentation system on excel or a computer formula management system, when implemented.

·  In conjunction with QA, determine the necessity for conduction IQ/OQ validations.

·  Write and execute all master validation protocols.

·  Analyze new products to be made at the company for manufacture worthiness.

·  When requested, determine theoretical line speed, bulk consumption rate, equipment capacities

·  Select prospective processing and filling equipment

·  For new technologies to the company, conduct an engineering analysis to determine the equipment and associated costs to run a new business

·  In conjunction and through Project Management and Planning, conduct pilot runs and prepare all related reports.

·  Create filling line schematics in coordination with Industrial Engineering.

·  Conduct orientation meeting with plant engineering to discuss new products and attend all project planning meetings.

·  Assure that all the company's SOPs relating to manufacturing, cGMPs, etc are followed including all accurate and complete documentation. Manufacturing

·  In conjunction with the Manufacturing Manager, determine batch size requirement for new orders and submit information or report to planning using available reporting methods and procedures.

·  Conduct first production runs of new products

·  When requested, arrange for client presence to approve first production quality with the company's QA

·  Provide manufacturing engineering and supervisory personal with equipment requirements and product specifications required to execute

  new/first time work orders

·  Trouble-shoot product quality and equipment problems in manufacturing.

·  In conjunction with the manufacturing manager, train and instruct pre-weigh and compounding personnel in proper batching methods and procedures.

·  Assist/Train manufacturing supervisors in technical aspects of new products.

·  Monitor product behavior to manufacturing specifications on an audit basis.

·  Assist (when needed) the Director of Engineering in Internet searches for new or used equipment. 

 Quality Assurance

·  With R & D assist QA personnel on the production line in making accept/reject decisions on new products and ongoing products and requested.

·  Trouble-shoot manufacturing issues.  Assist QA in responding to Quality Incident reports

·  Function as liaison to client companies to resolve manufacturing issues with product quality

·  In conjunction with Sales, alert QA on production start dates for new products and to ensure required specifications have been received and are available for start up.  Where specs are not provided, work with QA to get/develop specifications via client contact.

 Sales/Marketing

·  When required, attend open sales order meeting- Review with the company's staff any technical issues in manufacturing that may impact product delivery dates

·  Assist in arranging for tooling to be made for certain new products

·  Function as the company's contact with key customers to generate client “buy-in” to the company

 

Special Projects

·  In conjunction with the Logistics and Systems managers, assist in the implementation of the computer formula management system when available .

·  In conjunction with Engineering, conduct special projects based upon the company’s desire to expand into new areas of manufacturing and processes.