Manufacturing Senior Tech

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: September 16, 2020

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we’re leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info.

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Success What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

Job ID SR0053824 Date posted 09/09/2020 Location Cambridge, Massachusetts

Primary Duties

With limited supervision this individual will perform routine and non routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Will support engineering and validation activities.

Responsibilities: Job Function and Description

Job Function and Description

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Responsibilities include

Troubleshoot and resolve process related issues

Create work orders as needed

Initiate and document minor deviations

Execution of critical and routine and non routine production operations

Informing management of events impacting schedule

Perform Batch Record, Log Book and Form Prep requests

Enter data in the Laboratory Information Management System (LIMS)

Review manufacturing documentation real time to ensure compliance

Coordinate sample preparation and testing

Propose and review document revisions

Carry out work in a safe manner, notifying management of safety issues and risks

This individual will manage equipment and support facility related projects by

Act as subject matter expert for improvement projects

Perform scheduled cleaning of equipment

Assembly and disassembly of process equipment

Perform standardization of equipment

Support change over activities

Execution of equipment and process qualifications and validation

Working with supervision this individual will

Provide technical training for area personnel

Provide input on training material development

Meet and maintain training requirements

Develop and maintain personal development plan

Provide annual performance self assessment

Education and Experience Requirements

Essential: Normally requires a high school diploma and 4-6 years related industry experience or an Associates Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.

Key Skills, Abilities, and Competencies

Substantial understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered.

Will be required to perform as a subject matter expert for equipment and/or systems

The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.

Possess excellent communication and troubleshooting skills.

Full awareness of current Good Manufacturing Practices.

Proficient in Aseptic Technique

Ability to work cohesively in a team environment

Experience with business systems such as ERP, LIMs, and Trackwise

Will work holidays and overtime as required.

May be required to adjust work schedule to meet production demands.

Proficient in Aseptic Technique

Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.

Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.

Ability to stand for 6 hours in a production suite.

Ability to climb ladders and work platforms.

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

Ability to work around chemicals (alcohols, acids & bases).

Complexity and Problem Solving

Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making decisions

Limited to no supervision / instruction needed for routine task and minor direction for more complex/no routine tasks.

Clear understanding of manufacturing processes and the ability to readily identify deviations in process, controls, and guidelines required.

Will be responsible for identifying, supporting, and implementing process improvements

Internal and External Contacts

Internal

All Internal Manufacturing, Materials Management, Technical Operations and Facilities Management with limited exposure to support groups (Validation, Quality Control, Process Development and Health, Safety & Environment.

May require interaction with equipment, technical and supply item vendors

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0053824

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Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Manufacturing Senior Tech, Other , Cambridge, Massachusetts