Senior Engineer I, Validation

BeiGene • Hopewell, NJ

2d • Onsite

About The Position

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.

Requirements

• 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 cGMP’s.
• 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 cGMP’s 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.

Nice To Haves

• Knowledgeable in Computerized System Validation (CSV) and/or Automation Validation.
• Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.

Responsibilities

• Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP’s, 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level