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engineer, manufacturing

Title posted on indeed.com - Manufacturing Engineer - Validation

Posted on May 30, 2025 by Employer details Phyton Biotech

Job details

Phyton Biotech is hiring! 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 to ensure they are qualified, calibrated and maintained to regulatory requirements and industry standards. If you have a minimum of 2-3 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: *What Phyton Biotech will offer you:* Phyton Biotech determines an individual?s pay based on multiple factors including experience, education, job-related skills, and equity within the team or organization. The compensation range for this role is $67,000 ? 80,000. We encourage a progressive team environment with a work-home life balance by offering 3 weeks paid time off at the beginning of your employment (pro-rated in the first year based on start date), increasing with years of service, along with an innovative organization wide schedule of 9-day work rotation every two weeks. We strongly believe and encourage opportunities for training and development, including both internal and external opportunities. We provide an exceptional total reward benefit package to employees beginning their first day with extended health and dental benefits that include prescription medicine coverage, eye glass coverage, and orthodontic coverage, along with life insurance and an opportunity to participate in the organization?s retirement savings program with company matching after 12 months of service. *We are eager to connect with you, if:* · You can prioritize critical tasks and shift responsibilities on the fly · You are detail-oriented with an eye for quality, accuracy and completing work on time in a safe and efficient manner · You can work some occasional off hours (evenings/weekends) as required to ensure production is maintained · You are collaborative, but comfortable working autonomously with strong interpersonal and team skills You must be proficient using Microsoft Office suite of programs *A Day in the Department Would Include (others may be assigned, as required):* * Writing and/or approving specification documents * Writing and/or approving validation protocols and reports (IQ, OQ, PQ, DQ) for utilities, systems, and equipment, including computerized systems (CSV) * Maintaining the equipment management system to regulatory requirements and industry standards * Maintaining the qualification, calibration and preventive maintenance of equipment, utilities, and the facility * Developing and maintaining Engineering SOPs as required/needed * Providing engineering support for internal departments *Approval Authorizations (GMP) for the Role:* * 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 mu