Associate Director of Process Automation (m/f)
Would you like to fine tune all of our Process Automation activities and get them working in harmony? If so, we’d like to add you to our ensemble and enlist your support in bringing the new Hepatitis B vaccine Heplisav™ to market (US).
Your scope of duties:
You will set the tone for how Process Automation activities, including the calibration program for manufacturing, are performed and documented. Here, you must constantly ensure compliance with established procedures, applicable regulations, standards and industry best practices. You will report directly to the Head of Process Engineering.
Moreover, you will ensure the compliance and correct execution of automation activities associated with all site equipment/systems (i.e. QC labs, clean utilities and HVAC systems), while developing and introducing efficient automation, CSV and alarm system strategies. To do this, you will also write and review design documents such as URS, FDS or HDS.
As a site Subject Matter Expert (SME) for CSV, BAS/PAS, alarm systems and calibration, you will ensure that policies and procedures comply with the relevant guidelines. You also have comprehensive theoretical and practical experience in calibration activities.
In order to keep the daily work processes running smoothly, you will have oversight for purchases and budget adherence as well as for contractors (3rd parties). You will be tasked with recognizing the need for adjustments to equipment specifications and relevant change orders for the automation activities at an early stage. You will take on technical ownership of the entire automation equipment/systems and provide system administration. You will also take on a leading role in the automation section in FAT/SAT and qualification phases.
- You have 5-10 years of experience directly related to the job, gained in a biopharmaceutical commercial manufacturing environment
- You have profound experience in commissioning/decommissioning & qualification of process equipment, utilities and laboratory automation systems
- You are well-versed and experienced with cGxP procedures
- You know how to develop and approve URS/FRS, DQ, SFAT/HFAT, IQ, OQ, PQ and engineering documentation aligned with GAMP recommendations
- You are familiar with Good Automated Manufacturing Practice (GAMP), 21CFR Part 11 compliance, ISA S88 “Batch Control”, ISA S95 “Enterprise Control System Integration”, ISA 18.2 “Management of Alarm Systems”, QbD and QRM based on ICH Q8, Q9, and Q10 guidelines; experience implementing systems according to the ASTM E2500 framework is desirable
- You have knowledge of electronic quality management systems
- You are a self-motivated and organized person; a problem-solver who is able to lead change processes
- You have good communication skills and are fluent in both German and English
Are you ready to work in a challenging, but also dynamic and growing environment?
Then submit your application and make a difference in a position that gives you room to grow. We offer a competitive compensation package including benefits, a flat hierarchy and many opportunities for professional development. We look forward to hearing from you.
Please submit your application online.
Referenz: HP 127