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
we are driven to improve people's lives www.takedajobs.com Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx No Phone Calls or Recruiters Please. *LI-MJ1-USA Schedule
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.