Jeff Morrell Email & Phone Number

Montreal, Quebec, Ca

Program manager for ISO11607 sterile barrier, remediation, process monitoring infrastructure, and new technology for a world-renowned medical device manufacturer (Cook Medical).

Montreal, Quebec, Ca

Project management for the product and process remediation teams of a world-renowned medical device manufacturer (Cook Medical). • Create, update, and report on project schedules for more than 200 individual remediation projects related to Design History Files, Test Method Validation, Process Validation and other product and process remediation activities.• Develop deliverable prioritization tool to improve overall support staff throughput on critical deliverables over all remediation projects.

Project management for top 10 pharmaceutical company (Hospira, Inc. / Pfizer, Inc). Engineering SME for projects from Apr 2018 - Nov 2018. Served as account manager from Apr 2016 - Apr 2018. Supervision & development of packaging, validation, automation, process, & project engineers as well as project managers.•Manage capital finances ($29MM), schedule, & construction along with technical expertise for new biosimilar product *Oversaw lab remodel that was completed on-time & below budget *Remodeled freezer storage area. Yielded locations for 7 new storage freezers in existing floor space on-time & on schedule *Oversaw construction of tank storage room that was completed on-time & on budget *Oversaw construction of 20,000 sq ft new packaging & cold storage building, 15,000 sq ft building expansion, & new drug substance thawing room. Delivered on-time & under budget*Oversaw upgrade of aseptic fill line depyrogenation tunnel. Delivered on-time & on budget•Manage capital finance ($29MM), schedule, & construction for new aseptic vial filling line *Oversaw remodel of 4,300 sq ft aseptic fill suite. Delivered on-time & on budget *Oversaw remodel of 2,800 sq ft terminal sterilization in-process storage area. Delivered on-time & on budget•Manage capital finance ($1.4MM), schedule, & size change parts installation for an existing aseptic cartridge filling line. Delivered on-time & under budget•Manage capital finance($30MM), schedule, & construction along with technical expertise for new centralized aseptic commodities processing area *Oversaw installation & qualification of water for injection (WFI) still & high-quality steam generator. Delivered on-time & on budget *Oversaw remodel of 7,000 sq ft central commodity preparation area. Delivered on-time & on budget for equipment installation *Completed validation of first commodity•Oversaw financial closeout of capital projects on-time to specifications•Successful implementation of strategic account management

Corporate account management for a top ten pharmaceutical company contract client (Bristol-Myers Squibb). Site account management of all customers in the Evansville, Indiana; Louisville and Lexington, Kentucky; and Cincinnati, Ohio areas for both Clarke Engineering Services and Acquire Automation (Bristol-Myers Squibb, Toyota, Teva, Summit Biosciences, Amylin, Berry Plastics, Kerry Ingredients, and others). Project management for oral solid dose, oral liquid dose, and oral powder dose manufacturing and packaging at a top ten pharmaceutical company contract client (Bristol-Myers Squibb). Supervision and development of a fifteen member business unit containing packaging engineers, validation engineers, automation engineers, manufacturing process engineers, project engineers, and project managers. • Oversaw area contract growth requiring an increase in staff size from twelve in October 2012 to fifteen in November 2013 leading to a Business Unit Split. • Consistently exceeded sales growth targets of 5%. • Developed and funded project plan to correct implementation of serialization (track and trace) packaging pilot line implementation. First phase of implementation completed on time and in budget.• Modernized equipment qualification protocols for global manufacturer of depyrogenation ovens.

Project management for the asset delivery group for drug delivery device manufacturing of a top ten pharmaceutical company contract client (Eli LIlly). Supervision and development of a four member team containing packaging, validation, and project engineers. Serve as primary customer contact for asset delivery group. • Oversaw area contract growth requiring an increase in staff size from two in March to six currently - leading to the creation of a new supervisor position. • Expanded area sphere of influence by 50% from 10 work areas to 15. • Expanded customer support from pre-filled and reusable pen type injectors to include auto-injectors.

Project engineering for the asset delivery, process engineering, and maintenance groups for drug delivery device manufacturing of a top ten pharmaceutical company contract client (Eli Lilly). Supervision and development of a four member team containing packaging, validation, and project engineers. Serve as primary customer contact for asset delivery, process engineering, and maintenance groups. • Oversaw area contract growth requiring an increase in staff size from two in 2007 to six in 2012 - leading to the creation of a new supervisor position.• Expanded opportunities in drug delivery device manufacturing to project management, engineering, maintenance, commissioning, qualification, validation, change control, technical studies, and document control.• Expanded influence in drug delivery device manufacturing to asset delivery, process engineering, manufacturing technology, commercialization, maintenance, quality assurance, product stewardship, manufacturing science and technology, quality control labs, and test methods groups.• Led creation of commissioning, qualification and validation deliverables for a manual packaging line. Achieved system acceptance on time for a successful site product launch.• Led data cleanup efforts for customer site migration to a new version of computerized maintenance management software. Creation of 115 calibration data sheets. Implementation of a new site hierarchy; transfer of all site equipment to the new hierarchy; correction of location data; correction of asset data; and correction of pm data. 17 data certification and verification protocols and one validation report was created, executed, and closed.

Project engineering for the commercialization and operation groups for drug delivery device manufacturing of a top ten pharmaceutical company contract client (Eli Lilly).• Led creation of commissioning, qualification and validation deliverables for three pre-filled delivery device assembly and packaging lines at a customer site. Launched production on the first line, a manual assembly and packaging line on time for successful product launch.• Led periodic quality evaluations on chill room storage areas at two regional distribution centers for customer.

Troy, Michigan, Us

Project and facilities engineering for the finished products distribution sites of a top ten pharmaceutical company contract client. Support was provided to sites in Indianapolis and Plainfield, Indiana as well as Enfield, Connecticut and Fresno, California.• Developed and executed installation and operational qualification packages for 15 HVAC units used in Control Room Temperature (CRT) storage areas and 8 chart recorders used in both CRT and Refrigerated storage areas, in addition to other pieces of equipment.• Improved temperature distribution in a Control Room Temperature storage area with a better than 90% reduction in temperature difference in the warmest and coolest locations as determined by temperature mapping

St. Paul, Mn, Us

Capital and maintenance management in conjunction with project, process, and facilities engineering for bulk liquid batch mixing, liquid fill, packaging, warehousing, and distribution operations of both GMP and non-GMP institutional and commercial cleaning chemicals at the Huntington, Indiana manufacturing site of a Fortune 500 chemical company. Supervision and development of a team of ten maintenance technicians and planners. • Favorable expenses versus budget for maintenance department for the first time since acquisition in 1996.• Implementation of key performance indicators for the maintenance department including preventive maintenance backlog and planned to unplanned maintenance ratio. In first month reduced backlog by 17% and increased the ratio by 4%.• Increased line throughputs on two production lines by 10 to 67%.• Reduced downtime on a vertical-form-fill-seal machine by 55%.

St. Paul, Mn, Us

Production and quality supervision and development of a team of approximately 30 non-union manufacturing associates and material handlers for bulk liquid batch mixing, liquid fill, packaging, warehousing, and distribution operations of both GMP and non-GMP institutional and commercial cleaning chemicals at the Huntington, Indiana manufacturing site of a Fortune 500 chemical company. • Implementation of a new batch mixing scheduling spreadsheet that reduced overtime due to mis-scheduled production by 50%.• Established rapport with operators and reduced turnover rate by 75%.• Consistently had highest efficiencies of any shift.

Project, chemical process, and industrial process engineering of bulk liquid batch mixing, liquid fill, hard good manufacturing, packaging, warehousing, and distribution operations of both GMP and non-GMP, branded and private label products for personal care as well as commercial and household cleaning at the Great Bend, Kansas corporate office and manufacturing site of a leading provider of cleaning solutions. • Developed and implemented improved product costing spreadsheet.• Converted cookbook product design process to spreadsheet.• Upgraded propellant blending system, reducing setup times and improving blend quality control.

Paris La Défense Cedex, Fr

Process planning / engineering and production supervision of a team of approximately 15 union employees for bulk liquid batch mixing, bulk plant operation, and refinery quality control at the Arkansas City Refinery of Total Petroleum. Refinery ceased manufacturing operations in August 1996. • Converted pen and paper blend adjustment system to spreadsheet.• Created executive-summary style equipment manuals for use during sale.

Bs, Chemical Engineering

Master'S Of Engineering Management - Not Complete, Engineering/Industrial Management

Education record