TITLE: Quality Engineer (sterile products)
COMPANY: SCHOTT Pharma USA
LOCATION: Lebanon, PA
INDUSTRY: Manufacturer of pharmaceutical packaging solutions
COMPENSATION: Base salary plus 8-12% annual bonus
ATTRACTIVE SKILLS/EXPERIENCES:
- Bachelor’s Degree in Chemistry, Microbiology or related field (required)
- Experience (5+ years) of relevant quality engineering with sterile products/processes
- Experience (3+ years) related to product/process investigations, validations, instrument qualifications and EM Programs
- Proficiency with SAP, Minitab and MS Office
- Proven knowledge of cGMP and ISO Standards (9001; 13485; 15378)
- Experience in pharmaceutical or glass forming industry (preferred)
- Demonstrated communication skills (written / oral) including the ability to read/speak English
- Ability and willingness to work in fast-paced, matrix structured organization
SUMMARY / RESPONSIBILITIES: This Quality Engineer (Sterile Products) will plan, coordinate and implement quality projects related to Sterile production, to include, product/process investigations, audits, sterilization validations, instrument qualifications and Environmental Monitoring (EM) programs. Perform in-depth analysis and reporting to foster continuous improvement measures and initiatives. In addition, help define and implement short and long-term strategies to achieve departmental goals, along with site objectives and deliverables.. Other potential duties/expectations include (but not limited to)…
- Validation and re-validation of sterilization processes
- Lead regional or customer led improvement activities and support applicable rollouts
- Perform trending and monitoring of relevant quality KPls pertaining to Sterile products and related quality aspects; implement improvement measures accordingly
- Assure compliance with ISO certifications (ISO 9001, ISO 15378) and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines
- Support the laboratory side of engineering through method and equipment validation/qualification initiatives
- Manage and trend data from EM process, raw materials and finished product testing reltated to Sterile products
- Perform site based risk assessments
- Lead process mapping and continuous improvement activities using Lean principles and tools
- Monitor and support the proper implementation of change controls
- Support quality control plan analysis and improvements, including packaging development and execution of related projects and action items
- Coordinate, collect and analyze quality data for customers; troubleshoot and resolve customer issues; provide root cause analysis and corrective/preventative actions to eliminate
- reoccurrences
- Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner resulting from customer complaints, internal or customer audit findings
- Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports
- Develop and document best practice methods; ensure standardized procedures
- Participate in required trainings and meetings, when necessary
- Help promote and implement safety/EHS directives and maintain a clean and safe workspace
COMPANY: SCHOTT Pharma USA (Lebanon, PA) has been providing advanced solutions and services to the global pharmaceutical and biotechnology industries for over 100 years. SCHOTT Pharma USA offers an extensive and scientifically proven product portfolio including vials, syringes, cartridges and Fast Track Kits, for the safe storage and administration of injectable drugs worldwide.
Job Type: Full-time
Pay: $80,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Professional development assistance
- Tuition reimbursement
- Vision insurance
Application Question(s):
- Will you now or in the future require sponsorship for employment visa status (i.e. H-1B visa status)?
Education:
Experience:
- sterile products quality engineering: 1 year (Required)
- formal Quality Management System: 1 year (Required)
- ISO 15378, pharmaceutical GMP, or sterile manufacturing: 1 year (Required)
- writing commissioning, qualification, or validation protocol: 1 year (Required)
Ability to Commute:
- Lebanon, PA 17042 (Required)
Work Location: In person
