Summary: Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks. Tasks that may have multiple inter-coordinating elements. Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required. Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components. Interaction with peers and mentors on the individuals projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
Responsibilities:
Design, communicate, and implement operational plans for assigned engineering projects.
Monitor project progress and performance against established plans, timelines, milestones, and deliverables.
Identify and resolve operational or technical issues to minimize project delays.
Support and execute equipment and process validation activities, including IQ, OQ, and PQ.
Generate, review, and approve qualification and validation protocols and reports with minimal oversight.
Run studies and validations on manufacturing lines as required.
Support capital projects, continuous improvement initiatives, and cost improvement projects.
Support product transfer activities as applicable.
Lead and perform statistical analyses in support of engineering projects and validation activities.
Develop project schedules, budgets, forecasts, engineering designs, and work specifications as required.
Assist in the selection of materials, equipment, project resources, and external contractors.
Collaborate with Engineering, Technical Operations, Manufacturing, Quality, and other cross-functional teams to secure the resources and support required for project execution.
Conduct project meetings and prepare reports to communicate project status, progress, risks, and action items.
Set priorities, allocate tasks, and coordinate project resources to achieve established targets and milestones.
Incorporate risk mitigation strategies into project planning based on lessons learned, previous projects, and input from peers.
Review previous similar projects and activities to support technical decision-making.
Anticipate potential issues that could impact project timelines and proactively implement solutions.
Apply technical knowledge and an understanding of manufacturing operations and business objectives to provide effective engineering support.
Work independently and effectively with minimal guidance or supervision while maintaining appropriate communication with project stakeholders.
Qualifications:
Bachelor’s degree in Engineering, preferably Electrical, Software, Mechanical Engineering, or a related engineering discipline.
Minimum of 2 years of engineering experience or advanced education sufficient to achieve the required level of technical expertise.
Previous experience performing or supporting validation activities (IQ/OQ/PQ) in a Medical Device or Pharmaceutical manufacturing environment.
Experience with capital projects, continuous improvement, and/or cost improvement projects.
Experience with product transfers is preferred but not required.
Ability to generate and execute qualification and validation protocols and reports.
Strong project planning, organization, problem-solving, and analytical skills.
Excellent communication skills, with the ability to collaborate effectively with cross-functional teams.
Must be able to communicate effectively in both Spanish and English, verbally and in writing.
Ability to manage multiple priorities, anticipate potential issues, and work effectively with minimal guidance.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $25.63/hr - $27.00/hr.
