- Title: Manufacturing Engineer
- Code: RCI-08966
- Location: Barceloneta Puerto Rico (PR) 00617
- Posted Date: 07/20/2020
- Duration: 20 Months
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Position Title: Manufacturing Associate I (Engineer)
- Provide technical assistance to the Humira Bulk Drug Substance (BDS) Manufacturing areas (Inoculum, Fermentation, Capture, Purification, Buffer & Media Formulation, Weigh &
- Dispensing and Glass Wash & Autoclave) related to the manufacturing process and equipment. The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant.
- This position requires developing and implementing changes that will improve equipment performance and consequently product quality in the BDS manufacturing areas and reduce manufacturing costs, maintaining a constant product turnover.
- Develop and modify procedures as needed to support the manufacturing operation.
- Participate in process, equipment, and facilities validations efforts and projects implementations.
- Investigate process exceptions or equipment malfunction incidents affecting the process.
- Maintain the Manufacturing area equipment in compliance with the calibration and maintenance programs. Participate in the internal EHS and Quality audits.
- Give direct support to the manufacturing process and trouble shootings.
- Establish requirements and assist in the implementation of changes to the Process Control System.
- Develop and implement changes that will improve equipment performance and consequently product quality in the Bulk Drug Substance Manufacturing Areas (Upstream, Downstream and Central Services Areas) and reduce manufacturing costs.
- Investigate process and equipment exceptions and follow up CAPA implementation.
- Provide technical assistance to the manufacturing areas (Inoculum, Fermentation, Capture, Purification, Buffer & Media Formulation, Weigh & Dispensing and Glass Wash & Autoclave).
- Comply with Corporate and Divisional policies and procedures, ABL Plant procedures, and regulatory agencies regulations and requirements.
- Assist in the troubleshooting of the manufacturing equipment and process.
- Revise SOP’s and PCR and submit Change Requests (CR) for approval.
- Evaluate and implement new equipment technology.
- Participate in the development and execution of validation protocols. Participate in the manufacturing personnel training.
- Provide assistance to the Area Supervisor in the batch record audit process and discrepancies closures. Provide assistance during Regulatory Agencies Audits.
Demonstrated ability to contribute in a multi-disciplinary team environment.
- Provide technical assistance to maintain manufacturing equipment and process continuity avoiding losses due to poor production equipment performance.
- Should have a high degree of initiative and responsibility which would enable incumbent to perform efficiently with a minimum of supervision.
- Project Management Skills - Ability to take programs from concept to execution and manage all stages. Provide leadership to assigned teams by communicating and providing guidance towards achieving group objectives.
- Incumbent must work with other groups (ex. Maintenance, Engineering, Quality, Validations, Technical Operations/Tech Center, Computer Systems) influencing them to achieve their objectives to implement equipment and process improvements and at the same time, maintain a constant product turnover.
Bachelor Degree in Sciences (i.e.. Biology, Chemistry, Engineering). Preference in Chemical, Mechanical or Industrial Engineering.
- Excellent verbal and written communication skills in both, English and Spanish.
- Proven ability to effectively meet manufacturing goals by established dates in team setting.
- Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, and EN46000), knowledge of corporate, local, state, and OSHA regulation.
- Knowledge in manufacturing equipment’s troubleshooting.
- At least two (2) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
- Previous experience in manufacturing processes of biotechnological drugs, aseptic operations, parenteral drugs, solutions preparation, and sterilization operations preferable.
- Previous experience with Control Systems; Delta V and MES preferable.
1. Incumbent will deal with difficult technical problems in a highly technical and regulated biologics plant.
2. Must have the ability to focus, take initiative, cope with stress, and use judgment to accomplish results.
3. Excellent interpersonal skills that will permit effective interaction with peers, contractors, and customers.
4. Proven ability to effectively meet project goals by established dates in team setting.
5. Provide a team environment as to maintain highly motivated work force.
6. Must be able to communicate in English, both oral and written.
7. Excellent skills for managing teamwork with other departments of interaction.
8. Skills to operate computer automated systems.
9. Skills to understand technical information, in English.
10. Computer knowledge (Power Point, Excel, and Microsoft Word).
11. Ability to work with multiple priorities in a work environment with frequent interruptions.
- Are you open to look at candidates willing to relocate? > Note Virtual Interview process to be followed. N/A
- Years of experience/education and/or certifcations required:
2 years experience Educational Requirements Bachelor Degree in Sciences (i.e.. Biology, Chemistry, Engineering). Preference in Chemical, Mechanical or Industrial Engineering.
BS degree with an internship experience can be considered
What are the top 3-5 skills requirements should this person have?
1: Multiple project management at the same time – Change Request process
2: Demonstrated ability for Team Work
3: Fully Billingual
4: Excellent organizational skills, attention to detail, and strong oral and written communications skills
- What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Bachelor degree on Engineer. Pharmaceutical, Biotechnology or Healtcare Plant, or regulated industry is highly preferred.
- What type of environment is this person working in?
- Group setting
- Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours? Monday to Friday 1st shift 8-5
- Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? On Site
- Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling: N/A