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Pharmaceutical Manufacturing Site Lead

Company: Precise Solutions
Location: Lake Forest
Posted on: May 16, 2022

Job Description:

Job DescriptionAt Precise Solutions, we are looking for top talent consultants to bring on as employees of our organization and service our clients in the various Life Sciences Industries. We are much more than a consulting firm! Precise Solutions provides competitive compensation packages with great salaries, benefits, health insurance, paid time off and employer-based 401k contributions. We currently have an immediate need for the following:Job Title: Pharmaceutical Manufacturing Site Technical LeadClient: TBD-Research Based Global Pharmaceutical CompanyLocation: Irvine, CA USACompensation: TBD, compensation will be very competitive based on qualified candidate for the geographic location. Compensation includes competitive taxable hourly rate, Paid Time off, Company 401k contributions, Health, dental, and vision insurance. Note: Please do not submit resumes with candidate photos, they will not be considered.Job Description:The Pharmaceutical Manufacturing Site Technical Lead role in BLI, Irvine CA is critical to success of overall manufacturing operations by ensuring that IT systems and processes are maintained, compliant, secure and enable efficient and effective operations. A successful candidate will provide end-to-end technical solution leadership and business process alignment through the delivery and maintaining of Manufacturing and Lab Operational Information and liaise with Automation systems.

The role will liaise with Global/Enterprise applications and Infrastructure services team ensuring successful delivery of the site's infrastructure information systems.

This role also advocates on behalf of business stakeholders to ensure IT services meet their business priorities and needs, while improving operations and executing projects in a fast paced, multi-disciplined, cross-functional team environment.

This role includes a hands-on technical component to build, deploy, manage, and support manufacturing and laboratory GxP systems, as well as site infrastructure.Responsibilities:Provide technical expertise and day to day technical support to control systems, lab systems OT and IT systems. Responsibilities include adhering to change control/management, configuration control, compliance to system/data security policies and data integrity, patching, upgrades, backups, validation and qualification support, and user administration/management.

        • Support and provide domain expertise to site on GxP, data integrity, data Security as well as internal & external audits.
        • Facilitate internal resources and outside vendors in developing technical solutions for manufacturing and laboratory systems. Interface with equipment vendors to ensure successful machine delivery, integration, and manufacturing validation.
        • Support product, platform, and cost improvement programs by delivering qualified systems and acquisition software, machine controls and PLC/SCADA software. Interface with SQA, QA and Operations groups to successfully validate software systems.
        • Generate & Maintain documentation (SOP's & Technical Documentation) for full GMP validation and operation, including documentation of changes made.
        • Contribute to the Automation & IT Business StrategyQualifications:
          • Bachelors Degree.
          • 7+ years relevant industry experience
          • Exposure to FDA, HPRA, GMP, 21CFR11, safety and environmental legislation (Experience in the pharmaceutical industry preferred)
          • 3+ years proven track record in delivering IT & automation solutions in similar environment
          • 3+ years + project management experience – proven record of cross functional project delivery
          • Systems background: ERP, SAP, Maximo, RAM, MES, Data Historian (OSI PI), Chromatography (Empower) and laboratory management systems (NuGenesis, Acronis) SCADA/DCS an advantage
          • Knowledge of Quality Assurance, SLC, Compliance and Data Integrity
          • Ability to manage and support manufacturing layer Infrastructure in conjunction with global teams
          • Clarity of vision and courage of conviction to make good decisions
          • Ability to influence key stakeholders at site and global level in the company
          • Exercises latitude in the approach to problem solving.
          • Determines and develops approach and solutions to problem.
          • Broad knowledge of MS operating system, including server roles: AD, DNS, Virtualization, Remote Desktop, etc.Requirements:
            • Systems background: ERP, SAP, Maximo, RAM, MES, Data Historian (OSI PI), Chromatography (Empower) and laboratory management systems (NuGenesis, Acronis) SCADA/DCS an advantage
            • Knowledge of Quality Assurance, SLC, Compliance and Data Integrity
            • Bachelor's degree
            • Facilitate internal resources and outside vendors in developing technical solutions for manufacturing and laboratory systems. Interface with equipment vendors to ensure successful machine delivery, integration, and manufacturing validation.Top Nice to haves:
              • Exposure to FDA, HPRA, GMP, 21CFR11, safety and environmental legislation (Experience in the pharmaceutical industry preferred)
              • 3+ years proven track record in delivering IT & automation solutions in similar environment
              • 3+ years + project management experience – proven record of cross functional project deliveryDescription DetailsPowered by JazzHR5Qpjhzg9xT

Keywords: Precise Solutions, Lake Forest , Pharmaceutical Manufacturing Site Lead, Healthcare , Lake Forest, California

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