• Randstad
  • $94,360.00 -141,170.00/year*
  • North Billerica , MA
  • Scientific Research
  • Full-Time
  • 10 Meadowglen Rd


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Lead the configuration, administration and maintenance activities of the site manufacturing automation systems.

Responsibilities:

??? Working with our partner vendors, as well as internal subject matter experts, support project teams in the design, development, and qualification of automated processes, equipment, and systems.

??? Develop and/or manage the design of process control and automation systems in compliance with cGMP, GAMP, related industry standards and customer requirements.

??? Lead the development and/or review of user requirements specifications (URS), Functional Requirements Specifications (FRS), Hardware Design Specifications (HDS), Process and Instrumentation Diagrams (P&ID) for PLC and SCADA process control systems.

??? Working with the validation team ensure that the manufacturing automation systems meet all commissioning, qualification, and validation requirements.

??? Manage relationships with project and service contractors to ensure all aspects manufacturing automation systems are established and maintained to specification, on schedule and budget.

??? Directly support manufacturing operations with troubleshooting and issue resolution with respect to automation systems.

??? Identify and control risks to manufacturing operations posed by automation systems using appropriate risk management tools and engagement in contingency planning.

Working hours: 8:00 AM - 5:00 PM

Skills:



  • -5+ years of experience in the pharmaceutical industry
  • -Subject matter expertise on pharmaceutical manufacturing automation systems
  • -Bachelor's degree in engineering, computer science or related field
  • -Experience with Wonderware, Rockwell Automation and Vision Systems
  • -Experience commissioning and qualifying 21 CFR Part 11 compliant automation systems
  • -Lean experience and training preferred


    Education:

    Bachelors

    Experience:

    Experienced

    Qualifications:

    ??? Proven track record in execution of capital projects in the pharmaceutical industry

    ??? Knowledge of aseptic filling operations and barrier isolator technology

    ??? Experience with Johnson Controls (JCI) building management systems

    ??? Knowledge of commissioning, qualification & validation and other regulatory compliance requirements

    ??? Solid engineering capabilities related to reviewing and approving designs, equipment installation and specifications

    ??? Knowledge of electrical, mechanical and environmental engineering, HVAC systems, and utilities

  • Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
    Associated topics: antibody, aseptic, bacteria, biopharmaceutical, dietetic, food, histology, immunoassay, injury, nutrition

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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