Quality Engineer (Sterile Products)
Company: StarrTrax
Location: Lancaster
Posted on: April 30, 2021
Job Description:
Quality Engineer
POSITION: Quality Engineer (Sterile
Products)
COMPANY: SCHOTT Pharmaceutical
Packaging (Lebanon, PA) is a division of SCHOTT North America
and is one of the most respected suppliers of high quality glass
tubing containers for parenteral products in North America. SCHOTT
PPP offers technological leadership and innovation as well as
outstanding customer care for both local and multi-national
clients, whether it is packaging for liquid, lyophilized or powder
products.
COMPENSATION: 80,000 to 100,000
ATTRACTIVE SKILLS/EXPERIENCES:
- BS Degree in Chemistry, Microbiology or related technical
field (required)
- Experience (5+ years) in quality engineering with sterile
products (ETO sterilization preferred)
- Experience (3+ years) in product/process investigations,
validations, instrument qualifications and Environmental Monitoring
(EM) programs
- Demonstrated knowledge of ISO 11135
- Demonstrated knowledge of ISO 9001 and ISO 15378; along
with cGMP
- Experience in the glass forming industry and/or pharmaceutical
industry experience (preferred)
- Demonstrated knowledge and experience using MS Office
applications and SAP and Minitab
- Demonstrated technical writing and communication
skills
- Demonstrated communication skills (written / oral) including
the ability to read/speak English
- Ability and willingness to work in an office setting with
moderate noise
- Ability and willingness to work in fast-paced, matrix
structured organization
- Ability and willingness to work traditional Mon-Fri work week
(8am – 5pm) w/ flexibility
SUMMARY / RESPONSIBILITIES: This
Quality Engineer will plan, coordinate and implement quality
projects related to Sterile production, to include; product/process
investigations, validations, instrument qualification and
Environmental Monitoring (EM) programs. Perform in-depth
analysis and reporting to foster continuous improvements measures
and initiatives. In addition, help define and implement
short and long-term strategies to achieve departmental goals and
site objectives, while reporting on Key Performance Indicators
(KPI), when applicable. Other essential functions include
(but are not limited to):
- Validation and re-validation of Sterile processes, including
new cycle development with contractor(s)
- Lead regional or customer led improvement activities and
support applicable roll-outs
- Perform trending and monitoring of relevant quality KPIs
pertaining to Sterile products and related quality aspects; and
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
- Coordinate Environmental Monitoring (EM) program and seek
potential enhancement measures to the program
- Support the laboratory side of engineering method and equipment
validation/qualification initiatives
- Manage and trend data from EM, process, raw materials and
finished product testing
- Perform site based risk assessments
- Monitor and support the proper implementation of change
controls
- Support quality control plan analysis and improvements, to
include 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 correct/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 as a result
of customer complaints 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
- Perform other duties as assigned
Keywords: StarrTrax, Lancaster , Quality Engineer (Sterile Products), Other , Lancaster, Pennsylvania
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