- Bachelor’s degree required preferrably in Biology, Chemistry or equivalent life science – significantly direct relevant equivalent experience in lieu of a degree will be considered.
- A minimum of 4 years of supervisory experience in a quality regulated pharmaceutical or bio-pharmaceutical manufaturing company is required.
- Experience with aseptic processing, aseptic technique and operations in a clean room is strongly preferred.
- Knowledge of sterile manufacturing equipment and operation; steam autoclave, dry heat oven, sterilizing grade filters, pumps, weighing scales, temperature recorders, etc., highly desired.
- Candidates must be familiar with drug cGMP’s and the concept of Total Quality Control.
- Ability to communicate effectively with all levels of employees and management.
- Strong organizational, record keeping, and planning skills are essential.
- Strong leadership, interpersonal, and team building skills are required.
- The ideal candidate must be a team player, customer service oriented, willing to learn, and able to work flexible hours including some weekends.
- Bi-lingual in Spanish a definite plus.
- Computer literate and proficient in Microsoft Excel, Microsoft Office, and Microsoft Word.
- Excellent written and verbal communication skills required.
- Experience and knowledge in Continuous Improvement. Green, Black Belt certification is a plus.
- Knowledge in warehouse operations, material and personnel flow.
- Ensures that established policies, rules and regulations, and standard operating procedures (SOP’s) are followed. Reviews/revises SOP’s on a two year review cycle and prepare new SOP’s on an as needed basis.
- Verifies correct identification, weights, and warehousing of raw materials. Performs inventory control transactions for raw materials and components. Maintains Raw Material Disposition log. Reports vendor overages or shortages or material loss to Management.
- Orders and maintains the manufacturing supplies inventory.
- Troubleshooting process problems and participates in resolving any incidences that may occur.
- Ensure the accurate and timely review and completion of production batch records.
- Assist in planning and implementing the production schedule for smooth operations.
- Recommends modifications, improvements, and/or ideas to improve processes, raw material and finished goods handling procedures.
- Supervises daily activities of all production personnel and manufacturing operations.
- Responsible for batch production, employees, safety, and housekeeping of the area and meeting production quality and quantity standards. Reports any process and equipment problems to Management.
- Complete deviation reports, complaints, environmental notifications.
- Trains, evaluates, and reviews performance of sterile operators and packaging label operators.
- Prepares employee forms recording items such as attendance, overtime, vacation requests, and training.
- Maintains thorough knowledge of processes and equipment.
- Utilize experience, intelligence, and ingenuity in developing new strategy on process improvements and/or cost saving ideas.
- Performs other related projects or tasks as may be assigned by Management.
- Must be Safety oriented. Will participate in Safety Inspections and Safety program as Safety Committee member.
- Lead and/or provide support improvement initiatives across the site (Production, Engineering, Quality).
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com