Company Description Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.Job DescriptionThis position is responsible for coordinating and leading completion of all production support related activities to ensure timely execution of the production schedule in a manner that is complaint with EHS and quality objectives.The Production Coordinator role covers a broad range of responsibilities including daily production support, resolution of process issues, and safety/quality leadership. This role will also drive improvements in process uptime and building effectiveness, assistance to annual shutdown planning and execution, and participation in continuous improvement implementation.The Production Coordinator will coordinate production activities for their specified production area. These activities must be managed daily in a safe and environmentally sound manner while supporting overall business objectives.This position works closely with operations, technical, supply chain, quality, and maintenance to ensure continuous and efficient production in timely fashion, desired quantities, and desired quality. In addition, this position manages process safety and personnel performance. It requires coordination of delivery against standards established by cGMP, PSM, business expectations, and Continuous Improvement (Six Sigma, Lean, 5S, etc.). The person in this position must be able to provide leadership, development of team members, and execution of daily production activities in conjunction with improvement initiatives for the production area's assets. Key Responsibilities / Accountabilities
- Ensure all major and portable Production equipment is available/clean/operational for scheduled process
- Collaborate with Process Engineering, EHS, QC, QA, Regulatory to ensure all batch records are accurate, approved and issued to Production on time
- Ensure all raw materials have been sampled/tested/released before batch start
- Provide Production with all supporting documentation prior to start (Batch Record/starting material assay/packaging master/commercial packaging requests)
- Ensure each process has accurate bill of materials/consumables and have consumables onsite for process
- Update Standard Work Plans for processes and post in plant for when process is running; track and compare cycle times and yield; implement improvements through process After Action Review
- Collaborate on Process Training and provide training to Production shifts prior to manufacture
- Organize all investigations surrounding production deviations. Manage the open production TRs and collaborate with other departments to prevent records from becoming overdue.
- Organize and participate investigations surrounding EHS events.
- Monitor facility performance and drive improvement in productivity KPIs.
- Champion Continuous Improvement (CI) projects for the production department including Kaizen blitz, 5S, and area auditing.
- Work with Quality Assurance and production technicians to address documentation errors and batch record close within 7 days of completion.
- Executes projects in a timely manner, with attention to detail and follow through.
- Reviews and revises Production Work Instructions (PWIs), manufacturing batch records, deviations, and Standard Operating Procedures (SOPs) within the Veranova Quality system.
- Provide daily guidance to Production for plant priorities
- Represent Production in PHAs/PSSRs
- Participate in daily L2 SQDCP and weekly planning meetings
- Troubleshoot equipment and shepherd any facilities/maintenance work through RAM Request/ESR. Support production supervisors in trouble shooting and addressing production issues
- Update Production Readiness Review and communicate/escalate any impacts to business
- Assist with tech transfers, process scale-up, validation as needed
- Communicate, interact, and work closely with internal customers and external customers.
- Meet with regulatory agencies and customers during routine or non-routine audits.
- Provide plant tours to internal/external customers and other outside visitors
- Other duties as assigned
Special Factors
- Able to work with minimal to moderate oversight
- Occasional walking, standing for long periods of time while in labs/plant, reaching, handling, twisting, bending spine at waist when operating equipment
- May need to wear PPE while training or troubleshooting issues in the plant
Qualifications
- BS in Chemical Engineering, Chemistry or relevant technical degree w/ a minimum of 3 years' manufacturing, project management, and/or product team experience in the pharmaceutical industry
- BS degree in a non-technical discipline with a minimum of 7 years' manufacturing, project management and/or product team experience in the pharmaceutical industry
- Advanced knowledge of Microsoft Office (Word and Excel)
- Ability to lead and influence others
- Verbal/Non-verbal communication and technical writing
- Ability to independently apply scientific and/or technical knowledge in the performance of job duties
Additional InformationAll your information will be kept confidential according to EEO guidelines.Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.