Job Title: Validation Specialist

Details:

A Validation Specialist job in Clayton, NC is currently available through Belcan with one of our key International Pharmaceutical clients. In this role, you will be responsible for performing validation activities to support validation of a new facility and its utilities, Quality Labs, utilities and capital projects. In this role, you will be responsible for writing validation protocols and performing validation testing of a new facility that is being constructed. To be considered for this role, you will have a BS degree or higher in engineering or a scientific discipline and at least 1-2 years of experience in validation or quality systems and experience with pharmaceutical production and utilities. This is a 9 month contract position, with a strong possibility of extension to a long-term opportunity. This contract role includes a full benefits package, including medical, dental, vision, paid holidays, PTO, etc.

Validation Specialist Job duties:

• Actively manages and completes all phases of assigned equipment, facilities, utilities and process qualification and validation activities. Facilitates cross functional problem solving involving Quality Operations, Regulatory Affairs, Engineering and Manufacturing.

• Makes independent decisions within defined areas of responsibility.

• Write protocols, reports and validation master plans and assembles final validation report packets as required to meet qualification/validation objectives.

• Authors, reviews, and executes qualification and validation documents within a defined Quality system.

• Schedule and perform qualification and validation studies to meet timelines.

• Evaluate and analyze qualification/validation data collected, while verifying acceptability of the data and compliance with the protocol.

• Conducts discrepancy investigations and identifies and implements effective root cause corrective actions (CAPAs).

• Reviews engineering drawings (P&IDs, construction, as-built, flow diagrams) for compliance to GMP/Validation principles and provides feedback to project team for any noted deficiencies or improvements.

• Participates in meetings as the validation representative for assigned projects involving project planning, scope development, design, construction, startup, qualification, validation and administration.

• Interacts regularly with project team members and influences overall scope development and communicates with all levels of employees within and outside the team.

• Reviews qualification/validation turn-over packages for completeness and accuracy, compliance with policies and procedures and accurate data analysis.

• Prepare, program, maintain and use various data acquisition systems including Kaye Validators and Kaye Valprobes. Use other test equipment such as tachometers, thermometers, hygrometers and differential pressure monitoring devices as required for qualification protocols.

Qualifications:

• Requires a BS/BA degree in Engineering or a scientific discipline or an equivalent combination of education and experience may be considered.

• Requires 1+ years of related experience in the validation or quality field

• Experience in pharmaceutical processing and/or packaging and filling equipment (Bio-Pharmaceutical experience a must).

• Knowledge of FDA cGMP's, Regulatory Compliance, Standard Operating Procedures, QA/QC documentation, and GXP's as required, the ability to interpret engineering documentation a must.

• Knowledge of the principles of equipment design/operation and validation of at least 2 of the following is desired: Utilities (HVAC, WFI, clean steam, compressed process air and nitrogen), Filtration (Sterile, depth, filter presses), Purification (chromatography, ultrafiltration, nanofiltration), steam sterilization, Clean-In-Place systems and processing vessels.

• A technical background encompassing engineering, instrumentation, biology, chemistry, microbiology, statistics, and thermodynamics is desirable. Familiarity with plasma fractionation and purification, aseptic processing, filling, sterilization, GMP regulations, and Quality Operations are desirable.

If you are interested in this Validation Specialist job in Clayton, NC, please apply via the "apply now" link provided.

Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services-from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.

Job Requirements