OmniaBio: Associate I, Commissioning Qualification and Validation (Permanent or 12 month Contract)

CCRM and OmniaBio • Hamilton, ON

13d • CA$55,000 - CA$65,000 • Onsite

About The Position

The Associate I, Commissioning, Qualification and Validation, supports activities including development of validation master plan(s), and qualification/validation of deliverable(s) and standard operating procedures (SOPs). Responsibilities include assessment and development of qualification documentation for the facility, equipment and systems, and ensuring the documentation and equipment is compliant for manufacture to Good Manufacturing Practices (GMP) standards.

Requirements

• 1+ years of experience in a related CQV position in a biopharma/pharmaceutical GMP environment.
• Previous experience with CQV activities.
• Knowledge of clean room qualification and environmental monitoring requirements.
• Knowledge of the regulatory guidance for related aseptic, cell and gene therapy and regenerative medicine (e.g., Health Canada, U.S. FDA, EMA, ICHQ7, GAMP5, 21 CFR Part 11, ISPE, EU Annex, USP <1079.)
• Strong technical writing skills.
• Applicants must be legally eligible to work in Canada.

Nice To Haves

• Post-secondary education in engineering technology, or similar qualification, is preferred.
• Independent, detail-oriented, self-starter with excellent analytical skills, able to multitask and succeed in a team environment.
• Strong communication skills and able to work with internal and external partners.
• Possesses integrity.
• Demonstrates resilience and tenacity.
• Diligent.
• Works well with a team.
• Possesses interpersonal awareness.
• Has a high level of energy to persevere through challenging and demanding situations.

Responsibilities

• Validates master plan and deliverable development, including equipment, facilities, utilities, computerized systems and processes, installation qualification, operational qualification, and performance qualification. Ensures these documents meet the minimum regulatory requirements at an appropriate level of validation.
• Collaborates with key stakeholders and user groups, including Manufacturing Science and Technology, Process Development, Operations, Information Technology and Quality Assurance, to accurately develop documentation requirements.
• Maintains the validation activities schedule.
• Contributes to the development of SOPs, preventive maintenance and calibration programs.
• Prepares temperature mapping protocols and summary documents.
• Contributes to alarm rationalization assessments and management of required alarm documentation.
• Supports completion deviations, change controls, impact assessments, corrective and preventive actions and other associated records.
• Supports the development of risk assessments and mitigation strategies.
• Completes periodic review of commissioning, qualification and validation (CQV) documentation/SOPs.
• Participates in internal audits as a subject matter expert.
• Meets all deadlines associated with projects as directed, including all reports and documentation.
• Keeps the Manager, Commissioning, Qualification and Validation, , updated on all schedules, qualification testing results, and all other departmental activities.
• All other duties, as assigned.

Benefits

• An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
• OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree