Engineer Senior
📋 Role Overview & Responsibilities
Summary
The Senior engineer will lead activities in alignment with Client’s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The senior engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps.
Responsibilities
Be individually accountable for deliverables on key capital projects. This may include rationale development for improvements and identification of design requirement. In addition, translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive actionLead in the identification of critical quality parameters and process attributes for new equipment or facility modifications.Oversee and assist with development and execution of validation protocols in line with CQP and cGMP standards.Lead, evaluate, and manage performance of contract resources.Provide oversight for verification deliverables developed by outsourced/contract verification staff.Act as a liaison between Engineering, Manufacturing, and Quality Assurance during project planning, execution, and closeout.Lead and assist other engineers with troubleshooting, maintenance, and project management.Ensure safety during commissioning, validation, maintenance, and manufacturing activities.Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.Conduct and document periodic equipment validation reviews.Provide ad hoc technical support and guidance for manufacturing and maintenancePerform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)
Top 3 Must Have Skill Sets
Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work.Bachelor's degree in engineering or another science-related field with 5+ years of relevant work experience in operations/manufacturing environment
Compensation
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, experience, location and end client requirements).
Benefits and Ancillaries
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Frequently Asked Questions
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This position is located in Thousand Oaks, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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