Responsible for the organization’s manufacturing and/or production operations including assembly, machinery, processing, and/or packaging. Sets production schedules based on product introduction, equipment efficiency, materials supply, staffing resources, and volume required to meet demand and to ensure maximum production quantity and quality. According to regulations and planning, executes all common preparatory and finishing work for production. The production takes place in qualified areas so that a qualified substantiated procedure will be monitored daily. Works with moderate work direction and is skilled and knowledgeable about the position.
• Work with the manufacturing operations group, project design team, the CQV team, and the Automation/CSV reps to facilitate the development and validation of the manufacturing facility.
• Support Equipment Design/ HAZOP and Room programming reviews as per requirements.
• Support the Operations team to consistently deliver on specific area Key Performance Indicators (KPIs),e.g. EHS metrics, Production Plan, OEE, compliance, and team training.
• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
• Work as part of a dedicated process team where flexibility and teamwork is a key requirements.
• generate SOPS/Electronic Batch Records for a start-up.
• Adhere to the Right First-Time principals.
• Provide assistance and/or support maintenance, engineering, quality, or other
colleagues as requested.
• Escalate issues as appropriate to the Process Lead.
• Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
• Liaise with other groups and individuals to ensure the planning of tasks is effective and linked to the manufacturing process plan.
• Minimum of a Level 7 qualification in a science or engineering discipline.
• A level 6 with a minimum of 3 years of experience in a GMP Manufacturing requirement shall be deemed equivalent.
• Demonstrated successes in a team environment, such as project teams, Lean Six Sigma teams, etc.
• Demonstrated problem-solving capabilities.
• Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.
• Experience in a highly regulated pharmaceutical manufacturing environment is desirable.
• Start-up experience in a large-scale commercial drug substance facility is desirable but not essential.
• Good understanding of Upstream/Downstream Processing and experience an advantage.
• Ability to interact with multiple stakeholders across numerous departments
• Excellent communication skills and the ability to work in a cross-functional collaborative environment.
• Good interpersonal skills, attentiveness, and an approachable manner for interactions with inter-departmental colleagues.
• High degree of problem-solving ability and adherence to scheduled timelines.