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    CSV Engineer - Portsmouth, United States - PharmEng Nordic ApS

    PharmEng Nordic ApS
    PharmEng Nordic ApS Portsmouth, United States

    4 weeks ago

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    Description
    PharmEng is a leading Pharmaceutical and Biopharmaceutical Consulting company committed to delivering innovative solutions for our industries challenges. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are seeking a highly skilled and motivated CSV Engineer to join our team.

    Job Description:
    PharmEng is looking for a detail-oriented and results-driven CSV Engineer.

    Key Responsibilities:
    This role is a senior CSV engineer requirement.
    CSV /Automation experience of 5+ years
    Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / BAS (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
    Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
    Experienced at working independently as well as in a team-oriented, collaborative environment is essential
    Author, Review, Approve and Execute CSV life cycle documentation
    Experience working with and programming/commissioning/validating Delta V software platforms
    Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems
    Manage, document, and assess the software changes throughout the SDLC following Lonza procedures.
    Knowledgeable of S88 Batch Standard is preferable
    Recipe management DeltaV software development and testing is preferable
    MES Recipe authoring and testing is preferable
    Implementation and validation of QC system is preferable
    Experience with Kneat is preferable
    Strong verbal and written communication skills

    Qualifications:
    Bachelor's degree in engineering or a related field (e.g., Chemical, Mechanical, Biomedical).
    Proven experience in commissioning, qualification, and validation within a relevant industry.
    Strong knowledge of industry standards, regulations, and guidelines.
    Excellent problem-solving skills and attention to detail.
    Effective communication and teamwork abilities.
    Proficiency with relevant software tools and documentation systems.
    Strong organizational and project management skills.
    This role is 100% onsite.

    PharmEng is an equal opportunity employer and welcomes candidates of all backgrounds to apply.

    #J-18808-Ljbffr
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