Demonstrates an expert level of operational knowledge of sterile & non sterile products and their manufacturing processes to add value to investigations, evaluations and recommendations.
Demonstrates and applies an expert level of knowledge of manufacturing equipment.
Research and develop project 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.
Reviews and proposes changes to SOPs based on expert knowledge of equipment capabilities and operation.
Demonstrates a thorough understanding of regulatory guidance requirements and discusses them with Regulatory Affairs. 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.
Utilizes advanced statistical tools for analyzing process data from investigational trials, commercial manufacturing batches and Design of Experiments.
Understands and interprets standard and non-standard laboratory test results. 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 Senior Management and stakeholder groups.
Responsible for writing, reviewing and approving protocols and reports in support 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.
Works collaboratively with others in the same department and with all stakeholders to achieve agreed objectives. Assists with resolving issues escalated from more junior staff. Escalates issues further as necessary.
Participate and lead performance conversations with direct reports, including monthly one on ones, to connect on performance, check in on employee’s progress toward achieving objectives, offer support and remove barriers. Communicate and revisit performance expectations to reinforce and encourage high performance culture and safe working environment for all employees.
Onboard new employees by providing a consistent technical training & experience.
Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
Coordinate and manage all site Insurance renewal surveys for Bimeda. Risk assess, action and direct the closure of all insurance related deficiencies together with advising Executive and Senior management regarding options to mitigate current and potential risks.
Any other duties as assigned.
Minimum 8 years related experience. Sterile Manufacturing, Fill / Finish experience required, preferably in the pharmaceutical / biotech industry
Experience working in a unionized environment.
Related experience in pharmaceutical industry an asset
University/College Degree in an Engineering or Science related discipline required
Expert knowledge of the operational principles of pharmaceutical manufacturing equipment and processes (especially Sterile, Non Sterile, Solid Dose, Powder, Liquids).
Expert computer skills for Microsoft Office (Word, Excel, Powerpoint, Project, Outlook and others).
Capable of interrogating and finding data in standard computer systems (ERP, LIMS, Validator, Maint Mgt Systems).
Excellent verbal English communication skill sufficient to present ideas and proposals in to all levels in the organization.
Excellent document and report writing and reviewing skills, 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.
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 please send an email to firstname.lastname@example.org, 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.