Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clientsI in Puerto Rico.
Description:
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. Administrative shift (8am-5pm).
Competencies / Skills:
- Must have, at least, the following Amgen systems Knowledge:
a. MAXIMO – Owner (RSO)
b. CDOCS – Editor, Owner, Reviewer, Approver, Data Verifier
c. QMTS – Deviation Initiator and Owner, Change Control Owner
d. GDMS – Owner - Prefer Qualifications:
- 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
- URS’s, RD’s, DS’s 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)
- FAT's / SAT's 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 recurrenc
- 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
Responsibilities:
- Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures that affect multiple organizational units.
- 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.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
- Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
- Application of mature engineering knowledge in planning and conducting projects.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- 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.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Education:
- Master’s degree and 3 years of Engineering experience OR Bachelor’s degree in Engineering and 5 years of Engineering experience