- The Manufacturing Associate II performs and documents cGMP activities to support upstream and downstream production areas and operations . This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
- He or she may be responsible for training less experienced or new manufacturing associates.
- He or she may be responsible for supporting deviation investigations and may participates in cross functional projects teams, may support technical transfers with relevant teams/individuals and is involved in other assignments as directed.
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 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 to moderate troubleshooting of at least two 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.
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.
- 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.
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