Senior Commissioning/Validation Specialist
About the role
The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the design requirements and produce the expected results. This role supports the design and implementation of commissioning and validation plans for various types of facilities, including those involved in the manufacturing, storage, and distribution of drug products in GMP conditions.
Responsibilities
- Prepare and implement project commissioning/validation plans for existing or new buildings related to bio-pharmaceutical dosage forms, nutraceutical facilities, and other regulated FDA or similar facilities.
- Review shop drawings and equipment submittals to ensure compliance with design requirements.
- Create and review commissioning and validation plans, user requirement specifications, functional and design specifications, and other lifecycle documents.
- Develop and execute commissioning/validation protocols, addressing discrepancies and preparing final reports for project closure.
- Aid in client presentations and communication regarding project deliverables and business development.
- Coordinate with other Stantec engineering and client disciplines to align with design intent.
- Identify and address technical issues, escalating or initiating corrective actions as necessary.
- Participate in project coordination meetings and support project managers for Commissioning/Validation projects.
Requirements
- Good organizational and time management skills.
- Self-sufficiency and strong negotiation skills.
- Strong interpersonal skills.
Qualifications
- Bachelor's degree in Engineering with an emphasis in Mechanical, Electrical, or Chemical Engineering, or equivalent combination of education and experience.
- Minimum of 10 years of related work experience.
Skills
- Proficient in project management tools and techniques.
- Experience with commissioning and validation processes in pharmaceutical and biotech industries.
- Knowledge of regulatory standards and guidelines for pharmaceutical and biotech facilities.
Benefits
Regular full-time and part-time employees have access to medical, dental, and vision plans, a wellness program, health savings accounts, flexible spending accounts, 401(k) plan, employee stock purchase program, life and accidental death & dismemberment (AD&D) insurance, short-term/long-term disability plans, emergency travel benefits, tuition reimbursement, professional membership fee coverage, and paid family leave. Temporary/casual employees have access to 401(k) plans, employee stock purchase program, and paid leave, in accordance with state and local law.