Global Commercial Assembly & Packaging Engineer

Global Commercial Assembly & Packaging Engineer page is loaded## Global Commercial Assembly & Packaging Engineer locations:
Rockford, IL, USAtime type:
Full time posted on:
Posted Todayjob requisition :
JR116932

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
** We are PCI.
** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
** Summary of Objective:
** Global Commercial Assembly & Packaging Engineer, is a subject matter expert in high-speed automation with emphasis on device assembly and packaging.  This position will be responsible for developing standards and best practices in the equipment and automation space for all PCI sites.  This position will work with engineers and engineering leaders to ensure we uphold the highest standards consistently across PCI sites manufacturing drug-device combination products.

Working closely with clients and internal stakeholders, this position will evaluate emerging technologies in the drug delivery device space, identify product opportunities, work with equipment vendors to implement new technologies to our equipment set, skill set requirements by site and define a roadmap for success.
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* Essential Duties and Responsibilities:

** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
* Lead engineering standards and best practices for assembly & packaging equipment specification, build management, and commissioning in all PCI sites.
* Strategic focus for equipment specific technology development is appropriate to the PCI CDMO working environment.
* Work with Business Development and new clients to define equipment and process requirements Provide subject matter expertise and hands-on work during equipment design, FAT, SAT and validation to augment facility-based NPI resources.
* Maintain Quarterly Business reviews for responsible OEMs and drive KPIs to best in class.
* Develop a skill set gap analysis for engineers and technicians in the equipment and troubleshoot high speed automation assembly and packaging equipment.
* Develop an ongoing technical training academy to enhance equipment knowledge for our sites, support troubleshooting and reduce mean to time to recovery on equipment issues.
* Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned tasks.
* This position may require overtime and/or weekend work.
* Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position.
* Performs job duties as assigned by Manager/Supervisor.
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* Supervisory Responsibilities:

*** Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
* Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
* Independent business leader, strong team leading skills, no direct personnel supervision.
* Liaisons with key stakeholders across the organization to realize successful outcomes.

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* Qualifications:

** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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* Required:

*** Bachelor's or Master's degree in an Engineering discipline (Mechanical, Chemical, Electrical, Industrial, or IT equivalent technical field) is typically required.
* * Approximately 10+ years of experience in strong pharmaceutical assembly and packaging equipment knowledge.
** Extensive experience of structured problem solving and troubleshooting techniques.
* Advanced Computer

Skills:

Ability to perform the most complex computer tasks and operate various…