Summary:
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. 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.
Functions:
- 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 expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
- Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant 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.
- 2. Work with consultants, architects and engineering firms on development of standard design documents.
- 3. Obtain and critique quotes for equipment modifications or installations.
- Generate rudimentary project cost estimates and schedules.
* Other functions may be assigned*
Education:
- Master degree or Bachelor degree in Engineering & 2 years of Engineering experience.
- Engineering field (Mechanical, Industrial and/or Chemical) background.
Preferred Qualifications:
- General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry.
- Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.).
- Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards.
- Strong interpersonal, project management, technical problem solving and communication (written and verbal) skills.
- Ability to work in teams and adapt to a continuously evolving environment.
- Ability and experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.
Work Methodology:
- 100% On Site
- 12 months (1st Contract)
- Shift: General administrative with flex to support non-standard (2nd and 3rd shifts when needed).
- Professional Service Contract