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.
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.
- 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.
On rare occasions, travel may be required to offsite meetings or training event
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