What are the responsibilities and job description for the Process Expert position at Siegfried?
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
Your Role
The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The Process Expert should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help patients.
Responsibilities
Your Profile:
Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.
Your Role
The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The Process Expert should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help patients.
Responsibilities
Your Profile:
- Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
- Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records. Collect data for process qualification and implementation.
- Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
- Support process optimization, development of new processes, and introduction of new technologies.
- Lead equipment qualifications and improvement projects. Support the execution of process validations.
- Responsible for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining inventory of spare parts, coordinating repairs, making minor repairs in-house. Provide guidance, support, training, and knowledge to Production team.
- Take a leadership role in managing multiple projects.
- Coordinate internal resources and third parties.
- Supervise work of contractors.
- Create/maintain comprehensive project documentation. Work with Quality to ensure readiness for inspections.
- Ensure that all activities are in compliance with GMP, FDA regulations
- Capable of being trained in production of API and aseptic final drug product.
- Support cross-functional teams to address all site-related activities, such as urgent events that require technical expertise.
- Willing to fill in on production team.
- Understanding of Good Manufacturing Practices and ISO Standards
- Ability to push, pull or lift 50 pounds
- Understanding of aseptic processing or fill-and-finish operations
- Ability to be detail-oriented is essential
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
- Strong written and oral communication skills and knowledgeable of data integrity.
- Ability to multi-task is essential
- Flexible and able to adapt to company growth and evolving responsibilities
- Knowledge of MS Word, MS Excel, MS PowerPoint, data collection, and statistical analysis
- Bachelor's degree (biologic science or engineering discipline)
- 3 years' experience in a process support or development role in GMP manufacturing and/or QA/QC
- Previous experience with qualifying instruments and processes in a manufacturing facility
- Aseptic processes (equipment preparation, formulation, sterile filtration, and filling) experience is strongly preferred.
- Understanding of manufacturing processes in pharma, GMP, quality and regulatory aspects.
- Proficient in technical writing.
- At ease with following detailed SOPs and completing extensive detailed documentation (e.g., batch records) and patiently revising documentation following QA review.
- Attendance of production up to 50%. Typical production shift will be approximately: 3:00 PM to 12:00 AM. Ability to work overtime, weekends, and off shifts, as needed.
- Knowledgeable on PPE: safety glasses/goggles, hair net, mask, gloves, appropriate shoes, and scrubs under a lab coat or Tyvek suit.
- Medical, Dental, Vision
- Flexible Spending & HSA options
- Life Insurance, Short & Long Term Disability
- Pet Insurance
- 401K
Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.
Salary : $90,000 - $100,000