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

Commissioning Engineer, Pharmaceutical Manufacturing



**job details:**



+ location:North Billerica, MA

+ salary:$36 - $50 per hour

+ date posted:Thursday, July 18, 2019

+ experience:Experienced

+ job type:Temporary

+ reference:S_780400

+ questions:...@randstadusa.com978-###-####



**job description**



Commissioning Engineer, Pharmaceutical Manufacturing



Lead the commissioning of manufacturing equipment and facilities for an aseptic manufacturing operation.



Responsibilities:

??? Working with our vendors, as well as internal subject matter experts, write and execute commissioning and qualification protocols for new and existing equipment, facilities, utilities and manufacturing processes.

??? Participate and support the start-up and commissioning of equipment, including filling line, isolator, sterilizers, parts washer, air handler, chilled water, hot water, plant steam, clean steam, WFI, RODI and clean compressed air.

??? Partner with various system owners from manufacturing, facilities, process support and EHS to provide a high-level of customer service in ensuring proper equipment installation and operation.

??? Work closely with engineering to ensure that all project documents have been reviewed, walked-down, redlined, updated and appropriately filed in the engineering document management system.

??? Partner with validation personnel to ensure that commissioning documentation is performed in a manner to allow for leveraging in validation execution, where appropriate.

??? Lead the identification, documentation, resolution and close-out of non-conformances in the commissioning process.

??? Provide direction, input, review and approval of engineering studies, commissioning and qualification protocols and reports for facilities, equipment, systems and utilities to ensure quality and compliance throughout the process.

??? Lead troubleshooting efforts and serve as an SME in areas of strength when faced with process and equipment challenges, developing and implementing solutions with the project team.

??? Provide project management reports and presentations. Regularly communicate project status, including challenges and opportunities.



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



Skills:

--3+ years of experience in the pharmaceutical industry

--5+ years of experience in commissioning of equipment and/or facilities

--Bachelor's degree in engineering or equivalent experience

--Experience writing, executing and closing commissioning and qualification protocols



Education:

Bachelors



Experience:

Experienced



Qualifications:

??? Experience in executing pharmaceutical capital projects

??? Subject matter expertise on aseptic manufacturing equipment

??? Accountable and goal-oriented individual with ability to thrive in a team environment

??? Knowledge of process qualification & validation and other regulatory compliance requirements

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

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



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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: aseptic, biomedical, cytometry, drug, food, healthcare, immunohematology, medicine, therapeutic, transfection

* 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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