Manufacturing Engineer (Validation)

Job content

Phyton Biotech is growing! Check out our careers page for a newly posted position in the exciting pharmaceutical biotech industry, within the Maintenance and Engineering Department. Phyton Biotech has a welcoming and friendly company culture and offers competitive compensation packages.

We’re looking for a dedicated and highly motivated individual responsible for managing equipment and systems we use are qualified, calibrated and maintained to regulatory requirements and industry standards. If you have a minimum of 5 year’s experience establishing specification documents, such as validation protocols and commissioning documentation for equipment/systems, then we want to hear from you! Read the full job description here and apply for this exciting full-time, permanent role today:

Primary Responsibilities (others may be assigned, as required):

• Write and/or approve specification documents
• Write and/or approve validation protocols and reports (IQ, OQ, PQ, DQ) for utilities, systems, and equipment, including computerized systems (CSV)
• Maintain the equipment management system to regulatory requirements and industry standards
• Maintain the qualification, calibration and preventive maintenance of equipment, utilities, and the facility
• Develop and maintain Engineering SOPs as required/needed
• Provide engineering support for internal departments

Approval Authorizations (GMP):

• Authorized to approve equipment qualification, commission protocols and reports
• Authorized to approve process validation, cleaning validation, master plans, materials specifications, batch records, SOP’s, risk assessments, change controls, non-conformance, and engineering documents

Required Experience, Skills, & Abilities:

• Minimum 2-3 years of related experience required
• Engineering or Science Degree, or Technical Diploma Certificate required
• Must possess strong abilities with a proven track record in the qualification and validation of systems and equipment supporting GMP regulated processes. Pharmaceutical experience a great asset.
• Experience with Computer System Validation, CRF 21 Part 11, GAMP 5 and other related standards required
• Ability to work across multi-disciplinary teams and interact with all levels of the organization
• Must be able to handle multiple projects with multiple priorities; ability to adapt to changing needs of the business
• Equipment commissioning experience is desired
• Strong technical writing, communication skills, and excellent priority management skills required
• Strong computer skills and must be proficient using Microsoft Office
• Detail-oriented with an eye for quality and accuracy
• Collaborative, but comfortable working autonomously with strong interpersonal skills as a highly motivated self-starter
• Solid oral and written communication skills

This role is a permanent, full-time position that includes a competitive salary and benefit program along with appreciating work/home life balance by providing a 9-day work schedule. Interested applicants should email their resume (CV) attention: Claire Moore, Human Resources Manager.

We would like to thank all applicants who express an interest working at Phyton Biotech, however only those candidates selected for an interview will be contacted.

Job Types: Permanent, Full-time

Salary: $72,000.00-$80,000.00 per year

Benefits:

• Casual dress
• Company events
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• RRSP match
• Vision care

Schedule:

• Day shift
• Monday to Friday
• Overtime

Supplemental pay types:

• Overtime pay

Work Location: In person

Expected start date: 2023-09-18