This position reports to Days, 6 am 6:30 pm, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may be required to work overtime.
- Provide a brief summary describing the major role, responsibility and purpose of the job.
- Summarize key areas of accountability and budget responsibility, if applicable.
- With direct supervision this individual will perform routine manufacturing operations for the production of clinical and/or commercial products. Operates production equipment according to SOPs in their assigned areas
80% The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps:
- Execution of activities in support of production
- Perform requests and execution of GMP documentation
- Enter data in the Laboratory Information Management System (LIMS), MODA and or other business systems
- Sample preparation and testing
- Identify changes needed to documentation
- Complete required training on time
- Carry out work in a safe manner, notifying management of safety issues and risks
- Participate in tiered visual management system
10% The individual will manage equipment and support facility related projects by:
- Recognize issues and escalate to senior staff
- Perform scheduled cleaning of equipment
- Perform standardization of equipment
- Support change over activities
- Assist in the assembly and disassembly of process equipment
10% Staff Technical Training and Development:
- Maintain training requirements
- Develop and maintain personal development plan
- Provide annual performance self-assessment on development plan
- Education and Experience Requirements:
- Normally requires a high school diploma and 0-2 years related industry experience or an Associate s Degree in Life Sciences/Engineering field.
- Biotech Certificate preferred
Key Skills, Abilities, and Competencies:
- The individual should have the ability to perform functions such as: Following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
- Possess excellent communication and troubleshooting skills.
- Familiar with current Good Manufacturing Practices.
- Basic documentation and computer skills.
- Will work holidays and overtime as required.
- May be required to adjust work schedule to meet production demands.
- 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 up to 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).
- Familiarity with aseptic technique
Complexity and Problem Solving:
- Receives assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of objectives.
- Accomplishes tasks mainly through direct operation of cGMP activities.
- Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff.
Other Job Requirements:
- Travel to other MA Bio Ops sites may be required
- Valid license may be required for travel between sites
- May require weekend or holiday off shift support as needed
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.
Equal Employment Opportunity
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
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.