Planet Pharma · 12 hours ago
Sr Quality Engineer, Critical Systems
Wilson, NC
Full-time
Onsite
Senior Level
$35/hr - $52.44/hr
5+ years expPlanet Pharma is a company that focuses on quality oversight in critical systems within the pharmaceutical industry. They are seeking a Senior Quality Engineer to develop quality processes, support facilities, and ensure compliance with regulatory requirements.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develops Quality oversight of the facilities and equipment (critical systems) and associated processes, as well as the quality processes that govern them
Reviews developing change control (CC) for critical equipment and controlled areas with proper documentation supporting CC request
Performs impact assessments for Critical Systems requested for presentation to Change Control Review Board (CCRB)
Provides support to the Facilities department on items such as during maintenance activities and vendor work while also ensuring compliance
Provides quality oversight for change activities, equipment qualification, and facility commissioning and validation
Reviews and approves technical and quality documentation for critical systems
Troubleshoots equipment related to critical systems and equipment (Water, HVAC, Pest Control, etc.)
Reviews site and implements batch corrective and preventative actions to enhance compliance
Supports Engineering & Maintenance activities provided by vendors in areas not limited to: utilities, HVAC, and pest control to identify possible impacts and risks
Performs as the facilities and equipment quality system infrastructure to meet regulatory requirements (21 CFR 211)
Supports, coordinates, and communicates with quality processes and implementing solutions in alignment with company strategies
Performs and oversees investigations related to critical systems and equipment. Analyzes data, conducts root cause investigations, performs gap analysis and risk assessments, develops corrective or preventative actions, and implements procedural and physical changes to close gaps
Reviews and approves documentation such as validation protocols, engineering change requests, SOPs, IQ/OQ/PQ documents, etc
Reviews and approves quality documentation such as deviations, OOS, OOT, CAPAs, investigations, complaint data, batch records, and compliance assessments
Ensures adherence to quality and regulatory requirements while also driving continuous improvement
Performs and oversees documentation review and approval of technical changes
Supports engineering and maintenance teams
Participates and oversees quality project management
Maintains training system and ensures training is current and compliant
Participates in and may lead audits and inspections
Initiates change control and supports continuous improvement activities
Qualification
Required
Bachelor's or technical college degree, preferably in Engineering or related field
Minimum 5–8 years manufacturing experience with emphasis in Pharmaceutical Industry
Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
Knowledge of quality systems including deviations, CAPA, change control, complaints, and batch record review
Working knowledge of cGMP processes in pharmaceutical or medical device environment
Strong written and verbal communication skills
Ability to work cross-functionally
Strong problem-solving and analytical skills
Ability to manage multiple priorities and projects simultaneously
Proficient with Microsoft Office applications
Ability to work independently and in a team environment
Must have good technical written and verbal communication skills
Good organizational skills and good interpersonal skills
Must be flexible and adaptable
Ability to travel up to 10–20% as needed
Preferred
Working knowledge of SAP preferred
Experience With TrackWise And Documentum Preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase