Sr. Engineer- 34420

Summary:

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations manufacturing pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications experiments process and/or capital projects. Develops organizes analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Functions:

1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
2. Develop engineering policies and procedures that affect multiple organizational units.
3. Supervise coordinate and review work of a small staff of engineers associates and/or technicians on an ongoing basis as well as on a project basis.
4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area with overall responsibility for determining methodologies in that area.
7. Application of mature engineering knowledge in planning and conducting projects.

*Other functions may be assigned*

Design Engineering:

1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
2. Work with research manufacturing process development utilities facilities quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
3. Work with project managers to complete design and engineering projects within schedule budget and quality constraints.
4. Coordinate the work of consultants architects and engineering firms on development of standard design documents.
5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Education:

• Masters 2 years of Engineering experience.
• Bachelors in Engineering 4 years of Engineering experience.
• Preferred Eng: Mechanical Electrical or Chemical.

Preferred Qualifications:

1. MAXIMO Owner (RSO)
2. CDOCS Editor Owner Reviewer Approver Data Verifier
3. MTS Deviation Initiator and Owner Change Control Owner
4. GDMS Owner

• Work orders requestor approver may execute and document specific type of WOs (RSO) as applicable.
• Change Controls assessor.
• Change Control development & presenter.
• CAPA proposal and implementation plan development & presenter.
• URSs RDs DSs reviewer / approver /owner.
• Maintenance Master Package (MMP) reviewer / approver / owner.
• Test Runs / Protocols (PTCs) reviewer / approver / execution and/or support (may be author in very specific cases).
• FATs / SATs author / reviewer / approver / execution and/or support.
• Functional tests author / reviewer / approver / execution and/or support.
• IOQ / PQ reviewer / execution and/or support.
• P&ID and official drawings reviewer / approver / owner.
• SOP & Forms: author / reviewer / approver /owner (equipment systems) reviewer (process).
• Job Plans development reviewer and maintenance.
• Spare parts reviewer approver and maintenance.
• Provide troubleshooting support as required by operations / engineering.
• Analyze downtime incidents as per Equipment Failure prepare recommendations create action plans and execute to eliminate recurrence.
• Participate actively in the support of High Skills equipment breakdowns which could impact the operation with an extensive downtime.
• Perform or review equipment / system Root Cause Analysis investigations.
• Participate in risk assessment and continuous improvement initiatives (Kaizens critiques VSMs)
• Generate or support the generation of One-point-lessons for systems / equipment.
• Identify evaluate develop / design plan and implement solutions for equipment / process improvement opportunities.
• Development execution and implementation of corrective and preventive actions (CAPAs)
• Assist in generation of training materials and in providing training on scientific technical operations aspects of the equipment / systems.

1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. Able to develop solutions to routine technical problems of limited scope.

• Problem solving and applied engineering.
• Basic technical report writing.
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements.

• Basic technical presentations o Personal Organization o Validation Protocol Writing.
• Dealing with and managing change o Technical (Equipment Specific).
• Analytical Problem Solving o Computer Literacy.
• Specialized equipment/process expertise.
• In-depth knowledge of validation processes and requirements as applied to new equipment installations.
• Interacts effectively with variety of communication and working styles.
• Ability to independently determine when additional internal resources are required to solve problems.
• Ability to handle multiple projects at one time.

• Schedule developmento Facilitation.
• Collaboration
• Basic project managemento Completion and follow-up.
• Established expertise in at least 3 separate areas of engineering technology.
• Ability to independently determine when additional external resources are required to solve problems.
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
• Problem solving skills requiring the application of scientific and engineering theory andcalculations and creative skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools.
• Ability to delegate and manage the project work of others.

• Negotiation persuasion and facilitation
• Collaboration
• Project cost development
• Conflict Resolution
• Leadership and teambuilding
• Management of contractors and vendors.

• 100%-On Site
• 7 months (1st Contract)
• Administrative Shift: 8 am- 5 pm(weekends and overtime may also be required).
• Professional Service Contract