Sr Quality Engineer, Critical Systems

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
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).

SUPERVISION
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.

REQUIREMENTS
Education:
Bachelor’s or technical college degree, preferably in Engineering or related field.

Experience:
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.
Working knowledge of SAP preferred.

Skills & Abilities:
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.

ADDITIONAL REQUIREMENTS
Must have good technical written and verbal communication skills.
Good organizational skills and good interpersonal skills.
Must be flexible and adaptable.
Experience with TrackWise and Documentum preferred.
Ability to travel up to 10–20% as needed.

Pay ranges between 35-52.44/hr based on experience