BioVectra Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.
The candidate will be responsible for:
- Managing the Technical Writer, Team Lead and Process Technician group in the planning and execution of startup, process engineering, and validation batches.
- Working proactively with engineering during the validation planning phase to ensure the facility design will meet process engineering and validation requirements.
- Advanced design of the approach to process validation.
- Stewarding the client though the process validation experience.
- Ensuring the creation of process engineering batch reports and validation reports.
- Determining project resources requirements and hiring/contracting the personnel as needed.
- Training the validation Manufacturing Team.
- Scheduling, managing and directing the validation manufacturing Team.
- Ensuring cross departmental communications are maintained to achieve the process validation goals.
- Assessing progress made by each supporting operating unit to ensure each are working toward a common goal for the organization.
- Leading manufacturing non-conformance investigations and corrective actions. Accountability for prompt resolution of manufacturing issues which are likely to impact customer satisfaction and overall company operations.
- Writing and approving documents, procedures and SOPs generated for the manufacturing area.
- Participating in regulatory inspections and internal audits.
- Ongoing management of manufacturing activities post validation into continued GMP product manufacture.
The successful candidate for this position should have:
- Bachelor of Science in Chemistry, Chemical Engineering or Mechanical Engineering.
- Five years previous work experience in a pharmaceutical/chemical manufacturing environment.
- Experience with the start-up and validation of processes and equipment.
- Leadership experience.
Closing Date: March 14th, 2019
We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.