Manager, Quality Engineering
The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides
In order to continue our organic growth, we are constantly looking for talent.
The Manager of Quality Engineering is responsible for managing the Quality Engineers whom support validation and qualification of equipment, facilities, utilities and cleaning validation activities for API manufacturing. The incumbent will provide general direction for the QE staff. This position will work in close cooperation with Manufacturing, Engineering and other functional areas in managing validation activities under the QE scope of work. The Manager of QE/Validation will ensure validation activities comply with regulatory requirements and will present validation practices during regulatory and customer audits. This individual must oversee or plan and execute validation studies, write validation protocols, reports and other technical documents, as well as conduct validation related investigations.
- Manage, identify, hire, and develop a team to support validation activities at the Bachem Americas sites
- Manage continued growth, development, and retention of the team
- Collaborate with Manufacturing, Engineering, QA and other functional areas in managing validation activities under the QE scope of work
- Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases
- Oversee or independently develop a cleaning validation strategy for equipment and parts. Develop and execute or approve cleaning validation protocols and generate validation reports
- Oversee or independently plan and execute validation studies for equipment, facilities/ utilities and cleaning
- Write validation protocols, validation final reports and Standard Operating Procedures (SOPs), and technical reports
- Draft or review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures
- Manage contractors performing equipment and system qualifications
- Conduct and document investigations related to validation activities
- Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes
- Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirements.
- Contribute to GMP systems improvement
- Bachelor’s Degree in science related field (engineering, chemistry, biology or equivalent)
- Minimum of 5 years’ pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities) including experience in writing and execution of protocols, reports and operating procedures
- Minimum of 2 years of related experience in engineering, manufacturing or quality
- Experience managing direct reports
- Experience in pharmaceutical GMP manufacturing
- Strong knowledge of GMPs, FDA and EU guidelines/requirements related to validation
- Experience with root cause analysis, failure mode analysis and analyzing complex technical problems. Possess sound technical judgement.
- Experience in writing standard operating procedures and technical reports
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
- Master’s Degree in science or engineering related field
- Six Sigma Green or Black Belt
- Project management experience
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are
looking for a new challenge and want to join a motivated team in an internationally renowned company,
you should seize this opportunity.