Job Title - Principal Engineer l, Upstream Manufacturing
Work Location - Cranbury NJ
Job SummaryReporting to the Manufacturing Director in MFG 18, the Principal Engineer is responsible for leading a team of highly trained professionals in the manufacture of biological products in adherence to the highest standards of quality and regulatory compliance. Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GDP. The Principal Engineer will be responsible for the development of the team to consistently deliver on the specific KPI's and to meet with the expectations of our customers.
Responsibilities- Key member of Manufacturing leadership team for WuXi Biologics Cranbury. Will play an important role in the execution of the business plans, ensuring cross functional collaboration and leadership execution.
- Develop and drive team performance, training, communication, delivery of objectives, direction, goals, and performance management.
- Develop, motivate, coach highly functioning manufacturing team.
- Oversee the day-to-day operation of the GMP production, training, communications, assignment and prioritization of work, delivery of objectives, and performance management.
- Ensures that the plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements as required.
- Provide instruction, training, guidance, and technical support to the shift team during MFG operations.
- Lead the deviation investigation or quality issues and escalate issues promptly.
- Lead change controls and emergency change controls where required.
- Makes informed technical decisions where appropriate and escalates issues promptly.
- Lead cross-functionally and cross-shifts to resolve issues and drive improvements.
- Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
- Review and approve of area documents, SOPs, Batch Records, Logbooks and On-The-Job Trainings.
- Drive continuous improvement and operational excellence within the manufacturing process.
- Oversees the review of completed documentation and comment resolution.
- Where necessary assist in Facility and Equipment start up and Validation activities.
- Supports technical transfer activities.
- Flexibility to take on additional tasks and responsibilities at the discretion of the Manufacturing Director.
- Will act as a role model for the manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD cultureQualificiacatoins
- BS with 8+ years or MS with 6+ years in biopharmaceutical manufacturing with extensive experience in Upstream processing Extensive experience in leading teams, supporting the continued development of employees, motivating and engaging them to achieve their potential.
- Expert experience in dealing with and resolving employee grievances and maintaining a positive and progressive work environment/culture.
- Comprehensive knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry
- Experience of operating automated control systems such as Delta V, AVEVA, Unicorn or similar systems is desired.
- Experience of LIMS, SAP, Trackwise etc. is an advantage.
- In-depth knowledge of relevant cGMP, safety and environmental regulations.
- Expert knowledge and experience of the manufacturing equipment and associated processes.
- Excellent knowledge of the documentation standards and protocols in a pharmaceutical/biopharma manufacturing environment.
Behavioural Competencies- Strong leadership with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports.
- Excellent verbal and written communication and presentation skills.
- Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
- Ability to work on own initiative and be proactive.
- Results oriented, with the ability to manage multiple priorities in a short period of time.
- Excellent organisational and planning skills and strong attention to detail
Onerous requirements- Travel requirements, shift work etc. if applicable.
The job description does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
