This engineering position supports manufacturing activities associated with manufacturing process equipment at Client’s Rhoe Island (ARI). The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop, improve and oversee the operation and reliability of equipment.
Responsibilities:
Identify, support, and/or lead implementation of engineering-based improvements or
upgrades to the equipment systems. This may include development of reason for
improvement and identification of design requirements and then translation of requirements
into process equipment/system design, specification and supporting the construction,
startup, and validation of equipment.
Support Lean Transformation and Excellence in Operations process improvement by
leading, supporting, and documenting improvement opportunities to reduce cost, improve
safety/quality or improve speed.
Be individually accountable for the verification deliverables on key capital projects.
Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Develop commissioning and function test plan for any equipment modifications and acquisition.
Ensure safety during commissioning, validation, maintenance and manufacturing activities.
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Must Haves:
4 to 6 years Engineering and technical background on process equipment in pharmaceutical industry
No work gap more than 3 months
Demonstrated ability to work independently with minimal supervision
Demonstrated to be motivated to take on new challenges
Demonstrated ability to solve complex problems by being detail oriented and data driven
Has shown cross functional collaboration with multidiscipline functions such as process development, engineering, automation, maintenance and management
Preferred Qualifications / Skills / Experience
Bachelor’s degree in chemical or other Engineering fields
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical
operations/manufacturing environment
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and
familiarity with GMP quality systems/processes such as change control, nonconformances,
corrective and preventative actions, and qualifications/validation.
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, 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
IT Services and IT Consulting
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