Senior Process Engineer: temp-to-perm position

Senior Process Engineer

Provides technical discipline and leadership required to maintain, plan and implement robust and capable processes. Identifies and implements improvements and new technologies to processes to increase productivity, improve quality and reduce costs. Is the leader of equipment troubleshooting efforts; coordinating other support groups to return equipment to service. Is the leader of product/process failure investigations; implementing corrective actions and preparing sound scientific reports. Authors and provides technical support for developing processes and equipment documents including URS, DOE and validation documents. Provides change control authority to ensure the validated status of equipment is maintained. Reviews, monitors and trends daily operating data as needed, issues reports and recommendations based on operating data. Technical requirements include a thorough and demonstrable knowledge of cGMP’s and applicable Industry standards.

ESSENTIAL FUNCTIONS:

· Composing User Requirements Specifications (URS) for equipment and upgrades.

· Maintain control of area process changes and serve as the primary departmental owner of equipment management of change activities.

· Providing adequate and documented monitoring of the process through trending, run reports, and tracking Operational Equipment Efficiency (OEE). Use OEE to identify process improvements.

· Leading process troubleshooting efforts.

· Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.

· Identifying capital needs for the process.

· Support departmental change initiatives for continual improvement, specifically around Operational Excellence, 6-Sigma and Lean Manufacturing applications. Primary departmental driver for cost reduction initiatives.

· Facilitate technical transfers with R&D.

· SME for the process.

· Provides annual capacity analysis.

· Provides technical expertise to project management teams during project lifecycles.

· Executes projects, including:

· Purchases of equipment (lab furniture, laboratory equipment, process research equipment, etc.)

· Composing associated CER and processing financial information.

· Capital funding for outside services as it relates to manufacturing (risk assessments, validation services, process engineering assistance).

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

MINIMUM REQUIREMENTS:

· Education required/ preferred: Four-year degree in Mechanical, Electrical or Chemical Engineering. (Other engineering disciplines may be considered based on experience.)

· Experience: Minimum Five (5) years experience working as an engineer in a FDA regulated facility.

· Minimum two years of Manufacturing Experience; preferable in the manufacture of finished pharmaceuticals.

Preferred Skills/Qualifications:

· Verifiable knowledge of and experience in application of cGMP’s, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.

· Experience in applied knowledge of aseptic behaviors and techniques associated with pharmaceutical production.

· Experience with aseptic manufacturing equipment (Depyrogenation Ovens, Isolators, Lyophilizers, Liquid Fillers, etc.)

· Proven experience in leading teams, groups or efforts relating to processes and equipment.

Skills/Competencies: MS Office, Proficient in MS Excel

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

WORKING CONDITIONS:

Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.

This is a 3-6 month position

First shift

Contact:

Kevin M. Martin

(618) 580-7910