Manufacturing Associate II
Location:
Posted:
July 26, 2016
Reference:
1601367
OBJECTIVES:

The Manufacturing Associate II performs and documents daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments as directed. He or she may be responsible
for training less experienced or new manufacturing associates.

ACCOUNTABILITIES:

  • Performs/ assists with Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system.
  • Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records, SLRs, and equipment logbooks.
  • Actively participates in training activities, managing their individual training plan.
  • Is able to execute validation protocols relatively independently after training and instruction.
  • Utilizes Manufacturing knowledge to train others,  improve process operations and affect positive change and demonstrates ability to troubleshoot basic mechanical operations.
  • Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.

Qualifications
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Knowledge, competencies and skills:
  • Advanced knowledge of current Good Manufacturing Practices (cGMP's). Working knowledge of all relevant safety procedures  within the company. General understanding of most areas in Manufacturing and supporting functional groups.
  • Experience with cGMP Biotech or Pharmaceutical operations
  • cGMP: Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.
  • Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
  • Possess excellent written and oral communication skills.
  • Possesses advanced knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
  • Possesses advanced understanding of the scientific theory of biologics manufacturing:
  • understands biotechnology processing - purpose of major unit operations and microbial control concepts
  • Actively pursues learning of required skills, new skills, and new equipment
  • Understand routine procedures upon which they have been trained.
  • Possesses advanced equipment understanding, including understanding equipment function and application.
  • Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area
  • Ability to train less experienced or new manufacturing associates.
  • Proficient in MS Office and related PC skills
  • Must have the ability to work either Day or Night shift.

Education:
  • Bachelor's Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 1-2 years relevant experience, or Associate's Degree in a scientific or engineering discipline with a minimum of 2-4 years related experience, or High School Diploma with a minimum of 2-6 years relevant experience.
PHYSICAL DEMANDS: 

  • Is required to stand, operate manufacturing equipment, computer equipment; and is required to wear personal protective equipment (PPE) such as safety shoes, safety glasses and/or hearing protection.
  • May be required occasionally to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials.
  • May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in work campus).
  • May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
  • May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
  • May be required to drive rarely to attend offsite meetings and/or training.
  • May be required to use hearing occasionally when listening for production and equipment alarms.
  • Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
  • May be required to perform visual inspection of production equipment, materials, and activities.
  • May be required to perform occasional overhead reaching during handling of production materials/files/supplies.
TRAVEL REQUIREMENTS:
On rare occasions, travel may be required to offsite meetings or training event






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Schedule
Regular  Full-time
A little about us:
Takeda fosters an inclusive environment where all employees are empowered, supported and inspired to use their unique talents toward our mission to serve patients.

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