Engineer, Production
About the job
Job description:
JOB PURPOSE:
To analyse equipment and process capacity constraints in order to provide solutions that drive an increase in capacity, reduce equipment downtime, increase efficiencies and yield and support short and long-term business needs.
KEY ACCOUNTABILITIES:
- Sets up, runs, and Cleans equipment in Production Area and makes product following appropriate procedures in a clean and safe work environment meeting with all cGMP, JFDA, and other applicable regulations.
- the Production Operator is responsible for the finished drug product. The Production Operator position will execute these tasks manually or will be responsible for operating equipment that performs these functions.
- Sets up, maintains, and operates various pieces of computerized Production equipment.
- Sets up, maintains, and operates compression & coating machines.
- Performs line clearance of assigned Production lines as required.
- Performs visual inspection of drug product in accordance with SOP’s and cGMP’s.
- Maintains and ensures documentation, both written and electronic, is accurate, complete and factual as required by policies, procedures and regulatory guidelines.
- Completes and maintains applicable logbook and batch record paperwork as required.
- Provides input and suggestions for process improvements as well as for procedure writing and revision.
- Reports machines and manual deviations to area supervisor
- All other duties as assigned.
- Writing Production Level investigations and follow up on the production activities and day to day activities
- Writing CAPA and Annual product review
- Leads continuous improvement through process optimization of physical flow lanes (e.g., process troubleshooting, yield improvements) while ensuring compliance with government regulations and Hikma standards. Communicating effectively (verbally and in writing) as appropriate for the needs of the audience. Professional communication skills across a diverse workforce with the ability to resolve conflict in a professional manner and influence up, down and across the organization.
- Uses problem solving abilities requiring attention to detail, accuracy, cGMP, and scientific judgment.
- Applies detailed technical knowledge of manufacturing and/or packaging procedures performed, and documentation produced.
- Demonstrated experience and process knowledge in pharmaceutical manufacturing technology and / or operations.
- Technical knowledge and expertise to effectively contribute to product development activities. Strengthens the process-related technical skill sets of flow organization personnel through training and sharing of best practices.
- Provides leadership and mentoring to others within the organization.
- Advances the development of PCs through the collection and analysis of KPI’s, support of operator improvements
- Employee will be working Sunday – Thursday, including OT & weekend if needed, Employee may receive phone calls after normal business hours and on the weekends to trouble shoot, address, or assess potential issues in operations.
QUALIFICATIONS, EXPERIENCE, & SKILLS:
- Chemical and Industrial engineering or any equivalent major
- 0-3 years of Experience
- Ability to use computers to perform a variety of data-entry transactions and to retrieve information (procedures; safety, employment, and other information). Must be proficient in MS Office products (specifically Word, Outlook, and Excel).
- Ability to perform data entry/maintenance in SAP or equivalent systems.
- Good English language skills (especially in reading and writing) is required.
- Pharmaceutical or other regulatory (GMP) experience is preferred.
- Employee may be required to stand continually throughout the shift.
- Employee may be required to attend on morning or night shift with long shift is required.
- Employee may be required to attend weekend.
- Job involves frequent bending, twisting, pushing, pulling and lifting.
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