
Sr. Manufacturing Operations Associate
- Lebanon, IN
- $76,500-140,800 per year
- Permanent
- Full-time
- Assisting the Process Team Leaders with leading the Process Teams, specifically focusing on safety, quality, and manufacturing performance using appropriate performance metrics and targets.
- Ensure cGMP readiness of manufacturing areas for start-up and process qualification activities. Participate in and support training and engineering runs.
- Responsible for supporting validation activities and ensuring GMP production areas are within compliance.
- Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.
- When required (and per delegation procedure), in the absence of the Associate Director-Manufacturing provide continuity to the Process Team activities and operational aspects of the process; escalate issues to the Senior Director of Manufacturing Operations as needed.
- Lead or participate in continuous improvement projects through capacity optimization and cost reduction programs.
- Support the development and drive the Operational Excellence Roadmap for LP1 Flow Team.
- Lead Manufacturing Projects with the support of cross-functional stakeholders.
- Support authoring and revision of standard operating procedures and batch records as required. Review technical reports. Conduct deviation investigations and write process deviation reports.
- Document and appropriately communicate all aspects of work and learnings
- Provide training and mentorship for new personnel
- Bachelor’s degree in Engineering, Chemistry, Biology or related technical field
- 3+ years of Engineering, Chemistry, Biology or Technical Services Experience in a GMP environment (preference for pharmaceutical industry)
- Previous experience in utility operations (boilers, chillers, cooling towers, compressed air, distillation, tank transfer operation, batch processes, truck/rail operations)
- Demonstrated operational capability with high productivity
- Proven track record of curiosity with learning agility
- Demonstrated excellent problem-solving skills
- Self-starter with high initiative and data-driven approach to problem-solving
- Demonstrated ability to participate in and facilitate technical decision-making
- Demonstrated strong interpersonal skills with demonstrated adaptability and flexibility to working in different environments, teams etc.
- Demonstrated strong verbal and written communication skills
- Strong interest in leadership including cross-functional operations leadership
- Strong verbal and written communication skills
- Strong technical writing skills with attention to detail.
- Excellent problem-solving skills.
- An understanding of key technical services deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification.
- An understanding of normal process variability (expected) and special cause variability.
- Must be flexible to attend meetings or support off-shifts as necessary
- Some OUS and US travel may be required (