Engineer Senior

Max supplier submittal rate of * per hour Fully Onsite - Standard Hours - Occasional overtime may be necessary on an as needed basis.

!Candidates MUST be eligible to travel overseas up to 16 weeks per year.

Travel will be planned 2-3 weeks in advance!

Ideal Candidate: 4+ YOE, experience supporting a manufacturing line, and GMP or regulated environment experience.

Nice to have: relevant pharma experience, experience starting up a new manufacturing line.

In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns all the technical aspects in a manufacturing line.

The processes were the SO/LO Engineer shall be familiar with are: characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects.

Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.

Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams.

At the same time, the System Owner/Line Owner Engineer shall be able to define design requirements to the service providers to fulfill area technical and equipment needs.

Specific responsibilities include but are not limited to: * Provide solutions to a variety of technical problems of moderate scope and complexity.

* Under general supervision will evaluate, select and apply standard engineering techniques and procedures.

Assistance given for unusual problems.

* Perform assignments that have clear and specific objectives and require investigation of limited number of variables.

* Initiate and complete routine technical tasks.

Operations Engineering: * Function as a technical specialist to equipment or systems regarding problem solving operations.

Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.

* Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.

* Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering: * Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.

* Work with consultants, architects and engineering firms on development of standard design documents.

* Acquire and critique quotes for equipment modifications or installations.

* Generate rudimentary project cost estimates and schedules.

Preferred Qualifications: * Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering * Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations * Knowledge of pharmaceutical/biotech processes * Familiarity with validation processes for Packaging areas * Familiarity with serialization process and networking * Familiarity with documentation in a highly regulated environment * Ability to operate specialized equipment, tools and computers as appropriate.

* Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.

* Ability to apply engineering science to production.

* Able to develop solutions to routine technical problems of limited scope * Comprehensive understanding of protocol requirements.

* Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability * Excellent communication (verbal/written) and presentation skills * Demonstrated interpersonal skills including; collaboration, influencing, and facilitation * Protocol and script testing Writing * Dealing with and handling change * Packaging Equipment Technical knowledge * Analytical Problem Solving * Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations * Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Contex