PCI Pharma Services

PCI Pharma Services

Plant Engineer III

Bedford, NH, USA · Mid

Sponsorship not specifiedDetected 26 days ago
ComplianceProject ManagementExcelProcurementCustomer SupportSolidWorksAutoCADPLCVoIPGMPFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingWritingSCADA

About the role

  • Bridge to thousands of biopharma companies and their patients.
  • Demonstrates good engineering, effective collaboration, partnering and teamwork skills when interacting with internal and external resources.
  • Systems include water pretreatment, generation of WFI, plant steam, Clean Steam, Clean Air, Clean Gases, Plant HVAC, Fill Finish equipment and lyophilization.

Responsibilities

  • Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning & qualification Coordinating fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems including documentation of IQ/OQ protocols, executions, and summary reports
  • Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout.
  • Design and execution of engineering runs to test equipment or to troubleshoot problems. Design and execution of engineering runs to test equipment or to troubleshoot problems
  • Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment
  • Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure that PCI PHARMA SERVICES assets are well engineered and maintained throughout their lifecycles.
  • Procure new equipment, create and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering policies.
  • Support the execution of start-up and commissioning activities on Equipment, utility and GMP manufacturing Facilities, Systems, Utilities and Equipment.
  • Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing.
  • 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.

Requirements

  • BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
  • Strong understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles
  • Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system.
  • Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
  • Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point,
  • A minimum of 5 plus years' experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry.
  • GMP and non-GMP change control, maintaining regulatory compliance
  • Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.
  • Strong organization, interpersonal, oral and good written communication skills.
  • Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices.
  • Effectively support internal and external relationships, key stakeholders and vendors.
  • Excellent understanding of team and group dynamics.
  • Demonstrated agility to working in a fast-paced CMO environment.

Nice to have

  • Experience with aseptic liquid filling of vials, CIP/SIP and Clean Room, lyophilization, aseptic filling of vials, and aseptic processes, including refrigerated and frozen capabilities a Plus.

Benefits

  • Ensure risks to employee health and safety are rigidly controlled.

Company info

  • Together, delivering life-changing therapies.
  • We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
  • We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Equal opportunity

  • 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.

Visa & Work Authorization

  • 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 o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.