We are seeking a highly experienced and independent Senior Engineer to lead complex engineering projects, support capital initiatives, drive process optimization strategies, and resolve operational challenges within a GMP-regulated pharmaceutical or biotechnology environment. This role requires deep technical expertise, cross-functional collaboration, and the ability to manage diverse engineering activities from concept to implementation.
Key Responsibilities :
- Independently lead system and equipment design, implementation, and troubleshooting activities.
- Apply advanced engineering principles to resolve technical issues and improve production processes.
- Support operational teams by developing solutions for equipment downtime and recurring failures.
- Drive process improvements through data analysis, root cause investigations, and implementation of CAPAs.
- Lead and / or support risk assessments, validations, and continuous improvement efforts (e.g., Kaizen events, critiques, VSMs).
- Collaborate with cross-functional departments (manufacturing, quality, validation, utilities, facilities, etc.) to define requirements and implement engineering solutions.
- Coordinate with consultants, architects, and engineering firms to develop and review design documentation.
- Assist in the development of project budgets, schedules, and resource allocation.
- Supervise and mentor junior engineers, associates, and technicians on engineering assignments.
- Author, review, and approve engineering documentation, including :
- URS, RD, DS, SOPs, Job Plans, P&IDs, maintenance packages, and validation protocols (FAT, SAT, IOQ, PQ).
- Ensure accuracy and compliance with industry regulations and internal quality systems.
- Support execution and lifecycle management of validation documentation and change controls.
- Maintain equipment / system documentation through various electronic systems.
Competencies :
Analytical and critical thinkingTechnical writing and validation protocol developmentStrong organizational and prioritization skillsCross-functional collaboration and facilitationLeadership and team-buildingEffective verbal and written communicationContractor and vendor oversightAbility to manage multiple complex projects concurrentlyRequirements
Preferred Qualifications :
Bachelor's Degree in Engineering with 4+ years of experience, ORMaster’s Degree in Engineering with 2+ years of experience, ORDoctorate in EngineeringPreferred disciplines : Mechanical, Electrical, or Chemical EngineeringDemonstrated ability to lead large-scale projects and mentor technical teamsProficient in technical writing, problem-solving, and project coordinationSystems & Tools Expertise (Preferred) :
CMMS (e.g., MAXIMO) – work order creation, approval, execution, and documentationElectronic Document Management Systems (e.g., CDOCS, GDMS) – authoring, reviewing, approving documentationQuality Management Systems – deviation, CAPA, and change control ownershipExperience with equipment commissioning, qualification, and lifecycle documentationBenefits
6 months contractAdministrative Shift