Validation Engineer Job

Validation Engineer is needed to perform the following duties:

· Participate in planning, development, and implementation of manufacturing and lab equipment validation and qualification documentation.

· Review and execute the validation protocols (includes IQ, OQ, & PQ) for facilities, laboratory and support equipment, shipping, utility systems, and process equipment including cleaning validation.

· Represent validation during the creation of Validation Strategy Documents and other project-related documentation.

· Analyze and understand the GD & T for the generation of 2D drawings and converting the 3D drawings into 2D using Pro-E CREO.

· Lead and assist hold time program for study planned products

· Create and lead project tracking systems for planned hold time studies

· Author and execute bulk and intermediate stages of hold time protocols

· Support and train manufacturing operators for in-process characterization testing.

· Initiate and participate as appropriate in associated change control requests, deviations, CAPAs, and equipment acquisition documentation

· Work checked through consultation and agreement with others rather than by formal review of superior.

· Evaluate hold time data and initiation of hold time reports

· Initiate packaging and stability activities for products under hold time program.

· Work in a Kaizen and Kanban environment under the direction of the supervisor.

· Perform the risk assessment and impact assessment on the equipment and the instruments wherever applicable.

· Support the manufacturing department in implementing the 5S principles and standardizing the activities as a part of 5S.

· Perform creative and prevention to update hold time progress and closure

· Provide input into the development and maintenance of Validation related Master Plans, SOPs, work instructions, and forms.

· Coordinate the IT, Validation, and Quality Assurance departments for the development of Computer Systems Validation protocols, Set up the software in the equipment, and as assigning access levels to operators, supervisors, and admin-level access to a particular sector.

· Data entry using Excel for process characterization and process validation data and analysis as required

· Assistances in troubleshooting manufacturing and packaging areas.

· Experience in GMP/SDLC documentation and qualification execution.

· Prefer to have knowledge of PLC and/or DCS programming experience.

· Executing AIQ/AOQ & routing for post-approval.

· Prefer experience in drafting documents/executing docs in Kneat.

· Experience w/ isolators, filling machines, inspection machines, utilities, and sterile supply equipment.

· Experience with DeltaV hardware and PLC integration to DeltaV

· Should travel to FATs.

· Should follow status and schedule updates.

· Experience in AIQ/AOQ drafting & execution (drawing verifications/loop checks/hardware drawing verifications).

· Collaborate with Management to establish priorities and meet timelines.

· Should follow company policies and procedures.

· Independently manage the completion of priorities with limited instruction.

· Ability to communicate clearly and professionally both verbally and in writing.

· Work in/on DeltaV and other OEM systems (Allen Bradley, Siemens).

Bachelor's Degree is required in Mechanical Engineering or Engineering Management or Industrial Management.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave