Senior Engineer I, Validation

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates we look for scientific and business professionals who are highly motivated collaborative and most importantly share our passionate interest in fighting cancer.

General Description:

Engages in the day-to-day activities of the Validation function ensuring the successful management of related activities and large projects. Supports Validation objectives whilst adhering to regulatory compliance and achieving commercial success. This is a site-based position supporting the facility and will required gowning into the manufacturing suites.

Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met. Works to support Key Performance Indicators (KPIs) such as SOP mandated cycle times on time closure dates and objectives whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed to support the business. Works to support both internal GMP audits and Health Authority audits. Supports Validation related tasks as assigned by Management.

Responsibilities

• Develop and approve cGMP documents including but not limited to: Equipment and instrument Qualification Commissioning Master Validation Plans SOPs Comparability reports Aseptic Process simulation protocols and reports; process validation (PPQ) and cleaning/sterilization validation.

• Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT SAT IQ OQ PQ) etc.

• Ensuring that the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis as needed.

• Leading and Managing projects for the validation of equipment processes and products to meet all safety quality regulatory and operational requirements

• Review of equipment specification/design/procurement/installation and validation.

• Project planning and execution including scheduling task management milestone planning and reporting

• Generation review and approval of project documentation (User Requirement Specifications validation protocols reports) and Standard Operating Procedures

• Employee will be required to work closely with both manufacturing quality and engineer associates.

• Maintaining the validation sample management assessing the requirements for data acquisition and coordinating validation projects.

• Ensuring appropriate investigation of validation discrepancies errors protocol failures or validation testing errors requiring documented review and action to reconcile deviations.

• Position flows based on project needs up to and including quality approvals.

• Undertaking any other duties for any department within the business which may be requested by the Line Manager for which training and/or an explanation has been provided and understood.

Required Skills/Experience

• BS or higher in engineering and/or related discipline OR a minimum of 9 years relevant experience.

• Minimum 5 years of experience in biopharmaceutical manufacturing engineering and/or validation

• Scientific degree (ideally: pharmaceutical sciences engineering chemistry or related discipline).

• Strong knowledge of cGMPs.

• Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.

• Biotech and/or Sterile manufacturing and aseptic processing knowledge required.

• Minimum of 5 years experience in validation (with Bachelors degree) or 4 years (with a Masters degree) biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.

• Knowledge of cGMPs and Data Integrity principles.

• Demonstrable track record and skills/experience gained within a similar position(s) at a similar level. Good personal leadership.

• Good communicator (written and verbal) at all levels.

• Customer focused. Strong analytical and problem-solving ability.

• Hands-on approach with a can do attitude. Able to work under minimal or appropriate supervision level.

• Ability to prioritize demonstrating good time management skills.

• Excellent attention to detail with the ability to work accurately in a busy and demanding environment.

• Self-motivated with the ability to work proactively using own initiative.

• Highly Desirable: Good IT skills e.g. Microsoft Office (Word Excel PowerPoint Project and Outlook); working knowledge of SAP desirable but not required.

Preferred Skills/Experience

• Knowledgeable in Computerized System Validation (CSV) and/or Automation Validation.

• Highly Desirable: Good IT skills e.g. Microsoft Office (Word Excel PowerPoint Project and Outlook); working knowledge of SAP desirable but not required.

Physical Requirements:

• Ability to work in an office environment construction site and laboratory or manufacturing areas.

• May require up to 5% travel including visits to partner or manufacturing sites.

• Must be able to sit stand and use standard office equipment for extended periods.

Computer Skills:

• Proficiency in Microsoft Office Suite (Excel PowerPoint Word Outlook).

• Experience with project management tools such as Microsoft Project Autocad Smartsheet.

• Familiarity with data management and visualization tools (e.g. SharePoint Teams Power BI).

• Ability to create and maintain Gantt charts dashboards and tracking templates.

• Comfortable working within document management systems (e.g. Veeva Vault eQMS or similar).

Other Qualifications: N/A

Travel: May require domestic travel up to 5% travel

Global Competencies

When we exhibit our values of Patients First Driving Excellence Bold Ingenuity and Collaborative Spirit through our twelve global competencies below we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate including but not limited to job-related skills depth of experience certifications relevant education or training and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical Dental Vision 401(k) FSA/HSA Life Insurance Paid Time Off and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race religion color sex gender identity sexual orientation age disability national origin veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications merit and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Assistance Act of 1974 Title I of the Americans with Disabilities Act of 1990 and any other applicable federal state or local laws applicants who require reasonable accommodation in the job application process may contact .