Analytical Engineer

Summary:

Person will be working in a manufacturing environment but in this position we are looking for an engineer with strong ANALYTICAL skills and background



Day to Day Responsibilities:

This engineering position supports manufacturing activities associated with cGMP equipment and facilities.

The engineer will lead activities in alignment with companies 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 engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and investigate root causes of equipment issues.

The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.



The Engineer role will provide direct engineering technical support as follows:

Be individually accountable for the verification deliverables on key capital projects.

Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

Oversee development 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.

Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

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.

Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)



Preferred Qualifications / Skills / Experience:

Bachelor's degree in engineering or another science-related field

2 years of relevant work experience in operations/manufacturing environment

Direct experience with regulated environments (FDA, OSHA, EPA, etc.)

Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment

Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution

Demonstrated strong communication and technical writing skills

Strengths in facilitation and collaboration / networking with cross-functional groups

Experience in developing SOPs and delivering training

Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)

Problem solving skills using scientific and engineering methods and investigative skills for root cause analysis.





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 a number of factors, including but not limited to, a candidate’s qualifications, skills, 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.