Project Engineer, Quality Engineering

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The Process Expert is responsible for managing production instrumentation, optimizing existing processes, and developing new processes. The role requires initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. It exemplifies determination to meet ambitious goals/timelines, a customer‑service attitude toward colleagues, and motivation to help patients.

• Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, and reports.
• Perform technical writing/reviewing to support production operations, including SOPs, qualification protocols, and batch records; collect data for process qualification and implementation.
• Lead investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
• Support process optimization, develop new processes, and introduce new technologies.
• Lead equipment qualifications and improvement projects; support execution of process validations.
• Manage all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining spare‑parts inventory, coordinating repairs, and performing minor repairs in‑house.
• Provide guidance, support, training, and knowledge to the Production team.
• Take a leadership role in managing multiple projects.
• Coordinate internal resources and third parties.
• Supervise contractors’ work.
• Create and maintain comprehensive project documentation; work with Quality to ensure readiness for inspections.
• Ensure all activities comply with GMP, FDA regulations, and other applicable standards.
• Be trainable in API and aseptic final drug‑product production.
• Support cross‑functional teams to address site‑related activities, including urgent technical events.
• Willing to fill in on the 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.
• Strong attention to detail.
• Strong collaborative and influencing skills; able to work well in a cross‑functional, matrixed environment.
• Strong written and oral communication skills; knowledgeable about data integrity.
• Ability to multi‑task.
• 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 in a biological science or engineering discipline.

Minimum 3 years of 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.

Experience with aseptic processes (equipment preparation, formulation, sterile filtration, and filling) is strongly preferred.

Understanding of manufacturing processes in pharma, GMP, quality and regulatory aspects.

Proficiency in technical writing.

Comfortable following detailed SOPs and completing extensive documentation (e.g., batch records) and revising documentation after QA review.

Attendance of production up to 50%; typical shift 3:00 PM to 12:00 AM. Ability to work overtime, weekends, and off shifts, as needed.

Knowledgeable of PPE (safety glasses/goggles, hair net, mask, gloves, appropriate shoes, and scrubs under a lab coat or Tyvek suit).

Target Salary: $115,000 – 130,000.

• Paid Time Off
• Health Insurance
• Retirement Planning

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents, employing over 3,800 professionals. As a fully integrated CDMO, Siegfried uniquely handles APIs and finished dosage forms under one roof.