- Demonstrates an advanced level of operational knowledge of sterile & non sterile products and their manufacturing processes to add value to project execution, evaluations and recommendations.
- Liase with vendors/equipment suppliers, clients, third party consultants, contractors and other stakeholders as appropriate to understand the user requirements and ensure these requirements are incorporated into the equipment, process and facility as part of the projects.
- For all related projects - Research, develop requirements through engagement of key stakeholders, propose and justify approach and successfully project manage solution while strictly adhering to cost, quality, compliance, safety and delivery targets.
- Demonstrates a thorough understanding of regulatory guidance requirements. Accurately incorporates regulatory requirements governing proposed changes into written documents. Briefs stakeholders and senior management on the implications of regulatory requirements on projects and their timelines.
- Delivers effective and accurate project progress reports that can be analysed and understood at all levels within the organization. Utilizes advanced statistical tools for analyzing process data from investigational trials, commercial manufacturing batches and Design of Experiments.
- As part of PLCM Product investigations process, proposes appropriate non-standard testing in order to progress investigations and evaluations.
- Communicates and builds relationships with all levels within the company. Presents solutions and solicits feedback from management and stakeholder groups.
- Drive all functions to get critical activities completed in support of assigned projects Provide technical leadership to operations and oversee FAT/SAT/IQ/OQ/PQ activities as required
- Delivers all required document updates (SOP, MBR, Deviations, Specifications etc.) as required for the project and investigation work being conducted
- Ensures there is a strong safety culture and performance in the execution of projects. Works in compliance with all established Safe Work Practices (SWP) and the company SOPs and operational SOPs that enforce them. Understands the requirements and responsibilities for Environmental, Health & Safety and ensures that these applied.
- Organises, chairs and reports on meetings held to resolve technical and operational issues within scope of role.
- Utilise open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
- Adheres with all compliance programs and company policies and procedures
- Any other duties as assigned.
- Minimum 5 years related experience.
- Sterile Manufacturing, Fill / Finish experience required in the pharmaceutical / biotech industry
- University/College Degree in an Engineering or Science related discipline
- Expert knowledge of the operational principles of pharmaceutical manufacturing equipment and processes as they pertain to liquid filling (especially Sterile parenteral products)
- Strong knowledge of project management methodologies and industry best practice.
- Expert computer skills for Microsoft Office (Word, Excel, Powerpoint, Project, Outlook and others).
- Excellent document and report writing and reviewing skills using scientific language, capable of conveying information and proposals logically, clearly and unambiguously.
- Capable of completing project assignments independently and with good time management, escalating for clarification or decisions as necessary
- Strong written and oral communication skills in English
- A team player with excellent conflict resolution and leadership skills
- Demonstrated interpersonal savvy and relationship management/networking skills
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager
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