Job Description:

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Job Description

Job Title: Manufacturing Technician II

Location: Lexington (USA)

About the role:

With general management you will perform routine and important manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operate production equipment according to SOPs for producing clinical and commercial products

How you will contribute:

80%- You will manage cGMP manufacturing operations using

Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following:

• Troubleshoot and resolve process related issues


• Initiate and document minor deviations


• Implement important and routine production operations


• Perform Batch Record, Logbook and Form Prep requests


• Enter data in the Laboratory Information Management System (LIMS)


• Record data into logbooks


• Review logbook data


• Sample preparation and testing


• Propose document revisions


• Complete required training


• Accomplish work in a safe manner, notifying management of safety risks

10% You will manage equipment and support facility related projects by:

• Initiate work orders


• Assembly and disassembly of process equipment


• Perform scheduled cleaning of equipment


• Perform standardization of equipment


• Support change over activities


• Build equipment and process qualifications and Validation

10% - Staff Technical Development

• Meet and maintain training requirements


• Develop personal development plan


• Provide annual performance self-assessment on development plan

What you bring to Takeda:

Normally requires a high school diploma and 2+ years related industry experience or an

Associates Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing

experience. Biotech Certificate.

Experience with general aspects of the job with a broad understanding of the detailed aspects of the job

• May perform as a subject matter expert for equipment and systems


• You are proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.


• Full awareness of current Good Manufacturing Practices.


• Will work holidays and overtime.


• May adjust work schedule to meet production demands.


• Proficient in Aseptic Technique


• Work cohesively in a team environment


• Wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.


• Gown and gain entry to biotechnology/pharmaceutical manufacturing areas.


• Ability to lift equipment requiring up to 25-50 lbs of force.


• Stand for 6 hours in a production suite.


• Climb ladders and work platforms.


• Stooping or bending to check or trouble-shoot equipment operations.


• Work around chemicals (alcohols, acids & bases).


• What Takeda can offer you:


• Comprehensive Healthcare: Medical, Dental, and Vision


• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan


• Health & Wellness programs including onsite flu shots and health screenings


• Generous time off for vacation and the option to purchase additional vacation days


• Community Outreach Programs and company match of charitable contributions


• Family Planning Support


• Professional development opportunities


• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.


• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.


• Work in a cold, wet environment.


• Work multiple shifts, including weekends, or be asked to work supplemental hours.


• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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