Operations Engineering Manager

SHARP STERILE MANUFACTURING LLC•Lee, MA

About The Position

The Operations Engineering Manager is responsible for maintaining expertise with and making meaningful contributions to filling and related manufacturing operations to meet desired product specification for all BSM client projects of parenteral drug product manufacturing. The Operations Engineering Manager is responsible for broadly managing the novel creation of bespoke and general solutions for client-needs and / or quality parameter objections. This includes the management of staff, vendors, quality documentation, and functional requirements of process designs, implementation efficacy and training, and conception, fabrication, testing and induction of size or change part kits. The manager must be qualified for filling operations by media fill participation and contribute to contemporaneous process monitoring, improvement, and troubleshooting all fill related operations.

Requirements

Five plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired
In the absence of above, 5+ years of hands-on work in a technical field performing research, or field work utilizing scientific or industrial equipment.
Three plus (3+) years of supervisory/management experience
Advanced degree expected
Minimum of Bachelor's degree in Chemical Engineering, Chemistry, Biology, Engineering or Pharmaceutical Science AND relevant experience
Expertise with 3D / CAD modeling and ANSI drafting
Knowledge of scientific best practices
Excellent in technical writing
Knowledge of engineering first principles
Knowledge of parenteral drug product development and manufacturing
Able to work in a dynamic environment and adapt to changing priorities
Excellence in solving complex engineering and / or scientific problems
Able to handle multiple projects
Expertise with Microsoft Office
Familiar with Master Control
Project management skills
Excellent writing skills
Attention to detail
Written and oral communication skills
Ability to meet gowning requirements
Ability to remain stationary for prolonged periods of time
Ability to periodically lift up to 50 lbs.
Satisfactory audio-visual acuity
Gross and fine motor skills to manipulate instruments

Responsibilities

Work with operations, engineering, QA, maintenance, suppliers and management to resolve problems
Work with client to identify filling operation quality outcomes
Communicate with the clients and internal departments including upper management on project status and results
Prepare and review quality documents and reports
Suggest and partake in continuous improvement initiatives
Provide feedback on, and propose solutions regarding process improvement initiatives to improve operating performance
Lead CAD-based part designs to empower process improvement
Due diligence on process design and risk analysis to ensure operation safety, efficiency and quality
Review MFG operations batch records and other quality documents and reports
Review and approve study protocols to evaluate manufacturing processes and write associated summary reports
Create documents for operation and quality such as master batch records, working closely with the quality unit.
Develop and / or revise SOPs for equipment operations as needed
Accurately document and record (GDP) necessary data and reports with appropriate conclusions
Complete quality events such as deviation with sound judgement and scientific principal in a timely fashion
Maintain expertise on equipment with many degrees of freedom and manufacturing technology changes and core process technologies
Support daily activities in Manufacturing Operations and be able to work flexible hours and/or remain on-call for critical operations
Create and maintain control charts, key performance metrics and trending data from assigned areas to communicate process controls and improvements
Evaluate manufacturing processes and equipment and suggest improvements to increase reliability, throughput, minimize waste/rework.
Work directly with manufacturing management to identify key areas of equipment and process improvement
In conjunction with manufacturing personnel, evaluate new manufacturing equipment, prepare operating procedures and develop training.
Oversee modifications to manufacturing equipment as required/requested by Manufacturing, manage associated change controls and work orders
Have ownership of assigned equipment or business processes
Maintain up-to-date timelines and meet agreed upon deadlines
Source equipment and develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance and other personnel
Keep up industry knowledge and provide trainings in equipment and manufacturing technology
Other duties as assigned
Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable
Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements
Supervise/execute technology transfer of new processes or equipment
Support daily activities in the assigned areas and be able to work flexible hours and/or remain on call for critical manufacturing operations
Support validation activities including equipment validation and process validation
Lead problem solving and investigate quality events related to filling operations
Propose and lead process improvement initiatives to improve operating performance
Supervise, mentor, and develop team members or relevant personnel across departments