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JOIN OUR TEAM!
PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.
General Description:
We are looking for an Electrical Engineer for North Carolina USA
JOB SUMMARY
The Utilities Electrical Engineer is responsible for the development and implementation of
the strategies for the qualification of the manufacturing unit and equipment including
compliance to GMP.
KEY RESPONSIBILITIES AND ACTIVITIES
Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
Close liaison with the building contractors, engineers, and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols.
Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.
Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
As some validation activities will be outsourced, you will maintain these relationships, monitoring KPIs so that performance and value for money is maintained.
In addition to the contractors, manage other validation team member(s), including their performance, development, training, and compliance.
As a key member of the Quality team, contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders.
Key contributor in the project team to validate the manufacturing unit, working full-time on design, build and qualification activities.
Work effectively and supportively with other project team members to deliver the GMP manufacturing facility in accordance with the program.
Draft and review GMP documentation including validation documentation, SOPs, and training documentation.
Train team members in procedures relating to validation as required.
Participate actively in the preparation for the Manufacturer’s License as directed by Head of Quality.
Understand the production schedule, and work closely with Manufacturing and Engineering to build a qualification schedule that delivers minimum interruption to manufacturing output.
Work in a safe manner, ensuring full compliance to HS&E policies always.
Participate in and respond to inspections by Regulatory Authorities including
MHRA and FDA, representing the validation function.
Participate in continuous improvement in the manufacturing facility to enable production to be conducted effectively and efficiently.
Establish and maintain strong relationships with cross functional departments including Manufacturing, CMC, Engineering and Regulatory groups.
Actively maintain and update knowledge and expertise of current developments, standards, and operating practices within the ATMP and pharmaceutical industries.
REQUIRED EDUCATION AND EXPERIENCE
BA/BS in a scientific field of study with a minimum of 10 years of experience in the field of Validations from the Life Sciences industry (e.g. Pharmaceuticals, Biotechnology, Medical Devices, Cell & Gene Therapy)
At least 4 of leading and conducting validation activities in a GMP licensed facility that includes aseptic and/or sterile manufacturing.
Experience of validating a new GMP manufacturing unit.
Proven experience of managing compliance to GMP regulations and guidance.
Current working knowledge of GMP, and with a deep understanding of validation of cleanroom manufacturing environments and related equipment.
Ability to work consistently and compliantly, following standard operating procedures and quality policies.
Able to generate GMP documentation to a high standard and relating to validation including policies, SOPs, protocols, and reports.
Good communication skills; able to work with various team members across all functions.
Good understanding of Quality Management Systems and having a controlled approach to identifying and reporting deviations and completing CAPAs.
Experience of participating in the introduction of new processes and equipment into a GMP manufacturing facility.
PharmaLex is an Equal Opportunity Employer.
Job Types: Full-time, Temporary, Contract
Salary: From $40.00 per hour
Timeframe - 3 months
Work Location: In person North Carolina
Includes - Housing & Transportation.
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