Validation Specialist

4 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Title: Validation Specialist

Job Summary:

The Validation Specialist is responsible for ensuring the quality and integrity of pharmaceutical equipment and processes. This involves completing assigned tasks of equipment validation, packaging validation, and computer validation to meet cGMP requirements.

Responsibilities:

  • Prepare 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.

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 Proficiency:

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).

Compensation and Benefits:

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the 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.

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

EEO Notice:

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics, or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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