Validation Specialist

3 days ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Summary:

The Validation Specialist is responsible for ensuring the quality and compliance of equipment and processes in a pharmaceutical manufacturing environment. This role requires a strong understanding of cGMP regulations and the ability to develop and execute validation protocols.

Key Responsibilities:
  • Develop and execute URS, IQ/OQ/PQ protocols and write summary reports for production and packaging equipment, utilities equipment, and area qualification.
  • Ensure that assigned validation activities are performed timely and in line with current requirements and cGMP.
  • Coordinate commissioning activities for engineering projects of new areas and equipment.
  • Review and execute PPV (Periodical Performance Verification) of equipment.
  • Develop calibration plans for new equipment.
  • Prepare and train for setup, operational, cleaning, and maintenance SOPs.
  • Identify, investigate, and troubleshoot deviations for multiple concurrent projects.
  • Prepare personnel flow, incoming and finished material flow, and waste flow in the facility.
  • Assist in preparation of internal audit, FDA, DEA, and other agency audit responses.
  • Prepare, review, approve, and maintain validation project plans and summary reports and other validation lifecycle documents.
  • Write investigations and close them in a timely manner.
  • Create and close all change controls, CAPA, and investigations in a timely manner.
  • Create SOPs for facilities and utilities.
  • Monitor work order status and ensure completion correctly and filed, follow up with maintenance mechanics to close open work orders in a timely manner.
Requirements:
  • Bachelor's Degree in Engineering or Science-related field.
  • Technical and analytical ability to analyze engineered systems and equipment operation as well as quality and compliance systems that support production operations and research and development.
  • Good understanding of cGMPs and good documentation practices to prepare system life cycle technical documents such as URS, FRS, VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPs, Validation (PQ, DS, CV, PV), FMEA, and Validation Master Plan.
  • Technical knowledge to write, prepare, and execute change controls, investigations, SOPs, protocols, final summary reports, and validation documents.
  • Demonstrated excellent communication: verbal, written, and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • A team-building champion driving innovative cross-functional synergies.
  • Excellent project management and problem-solving skills.
Language Requirements:

The requirement for English language proficiency for this role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Benefits:

Employees are eligible to participate in Company employee benefit programs which include medical, dental, and vision coverage; life insurance; disability insurance; (k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

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