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Associate Manufacturing Engineer
Associate Manufacturing EngineerRangam • Sanford, NC, United States
Associate Manufacturing Engineer

Associate Manufacturing Engineer

Rangam • Sanford, NC, United States
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Rangam is seeking candidates for a Direct Hire role as an Associate Manufacturing Engineer with our client, one of the world’s largest pharmaceutical companies.

Seeking candidates in Sanford, NC or willing to relocate.

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will play a key role in accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us imagine new possibilities and bring them to life, ensuring that our solutions are both timely and effective. Your contributions will be essential in ensuring that our manufacturing processes are efficient, reliable, and of the highest quality, ultimately helping us deliver life-saving medicines to those who need them most.

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in client's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

The Associate Process Engineer supports the execution of Commercial, Clinical, and / or Development production according to Standard Operating Procedures and Production Schedule for mAb products . The Associate Process Engineer will work on interdisciplinary and cross functional teams, to own and implement process improvements, and lead / participate in process troubleshooting.

How You Will Achieve It

  • Supports manufacturing operations on the production floor for buffer / media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and / or UF / DF skids with varying levels of automation.
  • Point of Contact for the execution and issue resolution associated with process equipment commissioning, qualification and validation.
  • Owns troubleshooting, technical support / analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
  • Delivers Right first-time execution and continuous improvement; Monitor, Identify and / or Communicate process and compliance trends in real time.
  • Participate in the authoring role for controlled documentation; SOPs, Manufacturing Batch / Formulation Records, Forms, etc.
  • Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
  • Responsible for remaining current on assigned training.
  • Leads Lean Manufacturing, Sustainability and Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
  • Leads in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and / or quality compliance are at risk.
  • Generates work requests when issues arise with facility / manufacturing equipment. Provides support to maintenance to facilitate resolution, when needed. Point of contact for emergency work orders.
  • Skilled in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and / or QTS.
  • Identifies the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and / or to quality / compliance.

Here Is What You Need (Minimum Requirements)

  • Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
  • Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding
  • Working knowledge of Food and Drug Administration Regulations and Good Manufacturing Practices
  • Proactive, with experience in high-performance teams, strong interpersonal and project management skills
  • Strong written and verbal communication skills
  • Proficiency in Microsoft Applications
  • Ability to work effectively in a team environment and collaborate with cross-functional teams
  • Bonus Points If You Have (Preferred Requirements)

  • Demonstrated experience in a relevant manufacturing environment
  • Knowledge and experience with Drug Substance processing and equipment
  • Experience with process validation and equipment qualification
  • Familiarity with Lean Manufacturing principles and Six Sigma methodologies
  • Excellent organizational skills and attention to detail
  • Strong leadership and mentoring abilities
  • Ability to adapt to changing priorities and work effectively under pressure
  • PHYSICAL / MENTAL REQUIREMENTS

    Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This role is fixed Nights 2 / 2 / 3 twelve-hour shifts (6PM - 6AM) to support execution of mAb manufacturing.
  • Limited Travel 10%.
  • Work Location Assignment : On Premise

    The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in client's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with client's Matching Contributions and an additional client's Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver / parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at client's Candidate Site – U.S. Benefits | (uscandidates.my

  • benefits.com). Compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
  • Relocation assistance may be available based on business needs and / or eligibility.

    To find out more about Rangam, and this role, click the apply button.

    Satnam Singh

    SA Technical Recruiter | Rangam Consultants, Inc

    M : (513) 447-8917

    E : satnam@rangam.com| W : www.rangam.com

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