Quality Engineer - Validation
3401 Masons Mill Rd Bryn Athyn, PA 19009 US
The Quality Engineer - Validation is a key member of the Quality Assurance team, and serves as the primary specialist resource for development, execution, review, and approval of a variety of equipment and processes that are critical to the quality systems, production environment and laboratory spaces for the company. Primary responsibilities cover validation and FDA-compliance related documents/protocols for equipment qualification, (including laboratory equipment), process validation, test method Validation and related change controls to assure compliance with cGMPs in a medical device environment. As a key member of the Quality Organization this position will have the opportunity to utilize quality engineering skills and experience to help monitor equipment and processes for adherence to established procedures/regulatory compliance; this critical team member will also provide assistance and support to Industrial Operations and R&D to resolve complex, cross-functional process control issues and projects. This position reports to the Vice President, Quality Assurance & Regulatory Affairs.
- Author, review, execute and approve technical documentation, plans, protocols, and reports. This includes but is not limited to Equipment Qualification, Process Validation, Test Method Validation, related change controls, and SOPs for IVD and RUO products. Computer System Validation experience is helpful but not essential.
- Supports equipment qualification and requalification: laboratory instruments/systems, processing equipment, temperature controlled equipment, etc.
- Lead and Participate in quality- and process improvement initiatives and projects.
- Stays current with changes to GMP, including FDA, EU, ISO, and other regulatory bodies as well as guidance documents related to validation.
- Interact frequently with Laboratories, Manufacturing, QC and Facilities to provide expertise on equipment qualification and validation. Address conditions/practices with appropriate personnel; report findings to executive management as necessary.
- Works on routine assignments per written procedures; ability to recognize deviation from accepted practice.
- Participates and supports specific safety and quality responsibilities for department and site (i.e., GMP, Audits, Environment, and Health & Safety).
- Works and collaborates cross-functionally, primarily with R&D/Product Support, Industrial Operations, QC and Facilities.
- Manages and coordinates the use of third parties for the Installation and operational qualification of new equipment/Instruments/systems.
- Maintain the MSB US Validation Master Plan (VMP).
- Participates in cross-functional design, development and investigative activities (root cause analysis) especially in support of validation and qualification activities.
- Support and actively participate in third party audit and regulatory inspection activities
- Must embody the company’s Vision, Mission and Values
- Other quality related duties may be assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Quality Engineer experience in a Technical and scientific capacity
- Detail oriented and excellent organizational skills
- Excellent technical writing skills
- Project management
- Problem solving/analysis
- Continuous learning ability
- Customer/patient focus
This position has no direct reports.
This job operates in a professional office, production/lab and analytical laboratory setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines as well as standard scientific laboratory equipment and associated PPE.
This is an office-based position which will some activities in a production environment as well as lab setting; general movement is required. This would require the ability to stand for extended periods and to lift files, open filing cabinets, and bend or stand as necessary.
Position Type/Expected Hours of Work
This is a full time, exempt, professional-level position. Typical days and hours of work are Monday through Friday, 8:30 a.m. to 5:00 p.m.; this position may be eligible for hybrid work arrangements for qualified candidates.
This position does not typically require travel, but some activities may be necessary in cooperation with suppliers off-site.
Required Education and Experience
- Bachelor’s degree in a scientific or engineering (BioMedical, Mechanical Chemical Engineering etc), Biotechnology or Pharmaceutical Science, Quality Assurance, Manufacturing or similar is ideal.
- Minimum 3+ years’ experience in a GMP, FDA, and ISO regulated environment.
- Previous quality engineering experience / managing qualification and validation activitie
- Excellent oral and written communication skills
- Must be able to work independently and effectively as part of a team, exhibiting effective interpersonal skills
- Must be adaptable and team oriented.
- Excellent problem-solving ability.
- Experience with documentation and quality systems.
- Ability to work successfully in a cross-functional environment.
- Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work (network) environments.
Preferred Education and Experience
- Certification (i.e. ASQ, etc) in a Quality discipline (CQE, CQA, CQM)
- Experience in In vitro Diagnostics, Medical Device manufacturing or molecular diagnostics environment is preferred; background in reagent manufacturing would be a strong plus.
Please note this job description is not designed to cover or contain a detailed / comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Salary Range: $90-$110k
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.