Downstream Manufacturing Support Specialist

Job Description

We are seeking a highly motivated and experienced Downstream Manufacturing Support Specialist to join our team. In this role, you will be responsible for ensuring the smooth operation of our downstream manufacturing process. This includes working closely with cross-functional teams to identify and resolve issues, implementing process improvements, and maintaining high standards of quality and safety.

The ideal candidate will have a strong background in engineering or science, with experience in change management and technical writing. Excellent communication and organizational skills are also essential. If you are a self-motivated individual with a passion for process improvement, we encourage you to apply.

About the Role

This is a challenging and rewarding role that requires a high level of attention to detail and ability to work independently. The successful candidate will be responsible for:

• Working as a key member of the Integrated Process Team (IPT) to ensure on-time delivery of production schedules while maintaining alignment with site safety and quality standards;
• Providing oversight on material management, ensuring quality and delivery metrics related to material management are always maintained;
• Owning quality investigations from identification through root cause analysis;
• Providing oversight on day-to-day production quality metrics, ensuring on-time documentation closure, line clearance, and material management as per area SOPs;
• Driving continuous improvement projects related to schedule, equipment, and delivery capability within the IPT;
• Act as a link between shift operations team and day team, ensuring standardization and integration between all IPT teams;
• Supporting audit readiness in the Business Development and drive a permanent audit readiness culture within the team;
• Directing Root Cause Analysis (RCA) sessions for both safety and quality-related events, driving actions to closure with appropriate corrective/preventive measures;
• Leading/supporting area change controls, CAPAs, QSAT Actions as relevant per workstream as well as completing documentation updates as required;
• Providing ongoing coaching and support to cross-functional team members, to share process and operational best practices;
• Act as day operations member on process-centered teams (PCT), working with technical operations and shift operations to identify, perform root cause analysis, and develop corrective/preventive actions for issues as they occur.

Requirements

To be successful in this role, you will need to possess the following skills and qualifications:

• A Level 7 Degree in Science, Engineering, or other relevant disciplines/relevant experience preferable;
• Experience across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required;
• Experience in change management in a GMP environment;
• Experience in technical writing for GMP documentation and quality investigations;
• Self-motivated with excellent organizational skills;
• Excellent verbal and written communication skills;
• Proficient in Microsoft Office Tools (Word/Excel/PowerPoint);
• Ability to work independently and as part of a team in a cross-functional collaborative environment;
• High level of attention to detail;
• Experience working with GMP Documentation Management Systems;
• Good interpersonal skills;
• At minimum Level 7 in a relevant Qualification.

We offer a competitive salary and benefits package to attract and retain the best talent.

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