Sr Plant Engineer

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Department: Engineering
Reports to: Engineering Director

Experience:
- 5-10 years of experience in the design, calculation and management of comprehensive air conditioning and classified room projects in the field of biological research, formulation and production in the pharmaceutical industry.- Expert in regulatory and legal knowledge related to the design and construction of clean rooms in terms of their architecture, HVAC, laminar flows, and air treatment.- 5-10 years of experience in aseptic production environments in the pharmaceutical industry, valuable experience working with isolator technology in final filling processes.- 5-10 years of experience in of projects taking into account aspects of processes and production capacity, current regulations and user requirements, detailed description of the installation, room distribution plan and flow plans of materials, people and classified areas, among other aspects.- Expert in AutoCAD- English at minimum B2.2 certified

Functions:
The Plant Engineer provides engineering support to the manufacturing areas on issues such as process equipment improvements, technological advances, investment projects (CAPEX), existing manufacturing equipment, cost improvements, facility maintenance, safety and environmental regulation. You will demonstrate good engineering skills, effective collaboration, partnership, and teamwork when interacting with internal and external resources.- Support safety through personal commitment and promote individual responsibility for safety within the plant's Engineering Department. Ensure that risks to the health and safety of employees are rigorously controlled.- Provide engineering support for the execution of projects/tasks of facilities, systems, services and equipment from initial concept to final closure.- Within the field of engineering, having the ability to collect and analyze information related to the projects that are worked on; Be able to develop alternative solutions and work well in a team in problem-solving situations that arise. Provide technical support to the user regarding investigations, recurring problems, necessary modifications, optimizations, and continuous improvements.- Work with end users to develop system requirements, equipment/construction specification, manufacturing support, and performance of factory/site acceptance testing (FAT/SAT).- Assist in the preparation and review of user requirements (URS), Risk Assessments, Safety Assessments, and other engineering documents associated with facilities, systems, services, and equipment, as required.- Work closely with other departments such as Production, Quality Assurance, Validations/Qualifications, Operations and Maintenance, Engineering, Safety and Hygiene and Quality Control laboratories, to ensure that the company's processes are well designed and maintained throughout their life cycle.- Assist in Factory Acceptance Testing (FAT), Plant Acceptance Testing (SAT), configuration and commissioning of facilities, systems, services and equipment.- Procure new equipment, create and maintain appropriate engineering records, including equipment records and manuals, drawings and diagrams, and inspection reports in accordance with good engineering policies and in accordance with GMPs.- Support the execution of start-up and start-up activities of equipment, services and GMP manufacturing of facilities, systems, services and equipment.- Fix equipment/system failures, authorize deviations for unusual operations.- Manage quality events (change controls, deviations, incidents, corrective and preventive actions) as well as active participation in root cause investigations.

Benefits

At PCI, we believe our employees are our most valuable asset. That’s why we are committed to offering a benefits package designed to support your well-being and enhance your overall quality of life.

Here’s what we offer:
- Competitive salary- Health insurance + reimbursement for medication- English classes- Discounts on various activities- Partnerships with gyms- Referral programme

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Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _Opportunity/Affirmative_ Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
- At PCI, Equit