Facilities and Engineering Specialist
Summary The Facilities & Engineering Specialist will provide direct/indirect technical support for
pharmaceutical
development
and manufacturing operations.
The
role encompasses validation, metrology and preventive maintenance for various equipment/systems. The candidate
performs quality
functions to ensure
that equipment/systems and quality procedures adhere to system requirements and can perform properly and consistently.
Key Responsibilities:
Validation/Revalidation
o Develop documentation related to validation/re-validation. These include but are not limited to User Requirements, Risk Assessments, Installation, Operation and Performance protocol (IOPQ)
o Execute protocols, address deviations/non-conformance, and develop final reports for executed protocols.
o Coordinate with key stakeholders on scheduling logistics, execution and documentation closure.
o Review/approve protocols, reports and validation summary packages
o Where applicable, manage and provide oversight on vendor qualification support.
Metrology
o Where applicable, perform simple calibration that includes but not limited to temperature, pressure and relative humidity.
o Manage/provide oversight on vendor calibration/certification activities
o Review and approve calibration/certification reports
o Address relevant out-of-calibration and/or excursions
Facilities
o Develop, execute and address work orders (corrective and preventive)
o Provide oversight, review and approve vendor/contractor service work orders
o Respond to building/equipment alarms as needed
Basic Qualifications
Education:
Bachelor's degree in science or relevant discipline preferred but professional experience in appropriate role may substitute.
Experience:
3+ years of recent experience in one or more of the following areas:
o
Equipment validation
o
Metrology
o
Facilities maintenance
Skills:
Good understanding cGMP's, regulatory requirements, and quality systems.
Strong written and verbal communication
Good troubleshooting, problem-solving skills and attention to detail.
Sound knowledge in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).
Physical Requirements
Ability to move 50 lbs.
Ability to climb ladders and stairs
Must be able to perform repetitive motion activities during working hours
Occasional evening and/or weekends may be necessary
Ability to use basic tools with proficiency
What we Offer
Competitive salary commensurate with experience
Benefits package including health insurance, paid time off, 401k retirement plan, short and long term disability and life insurance.
On-site gym membership