Tech Ops Specialist – Control & Incoming Materials

Position: Tech Ops Specialist – Change Control & Incoming Materials
** Job Description
** Our Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your  this position within the Incoming Materials IPT within the Core Site Services E2E will be responsible for providing technical support and execution of change management system including projects associated.

The individual will be responsible for providing and occasionally leading technical support to the manufacturing areas. The individual will work as an individual contributor, adding to the performance and results of the department. Provides technical guidance. Anticipates and interprets client and/or customer needs to identify and implement solutions. Minimal supervision, guidance, and direction is employed by the supervisor, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.
** Individual will also be responsible for:
*** Authoring and updating technical and manufacturing documents necessary for engineering studies, change control.
* Support and/or execution of continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
* Completing projects to improve the performance of our processes, including supporting investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right
- First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
* Examination of an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
* Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
* Support of regulatory inspection activities for the facility.
* Providing on-the-floor support of operational and technical (process/equipment) issues on the shop floor, including GEMBAs, and/or troubleshooting initiatives.
* Supporting team safety, environmental, and compliance objectives.
* Managing project and support investigation timelines as needed to ensure key compliance and customer due dates are met; escalating any potential delays and developing remediation plans when possible.
* Collaborating effectively with the area leads, Operators/Mechanics, support groups, Quality, and Planning.
** Education Minimum Requirement:
*** Bachelor’s Degree or higher (Engineering or Sciences, preferred)
** Required

Experience and Skills:

*** Two (2) years post-bachelor’s degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories.
* Experience in change control and/or equipment support and/or project support role.
* Highly developed communication, leadership and teamwork skills.
* Ability to manage projects/work to schedule/deadlines.
** Preferred

Experience and Skills:

*** Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
* Change Control author
* Vendor Change Notification experience
* Deviation Management
* Experience working with Suppliers
*
* Required Skills:

** cGMP Compliance, Change Control Processes, Data Analysis, Detail-Oriented, GMP Compliance, Investigation Management, Manufacturing, Manufacturing Support, Process Improvements, Regulatory Inspections, Vendor Management
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and…