Perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen, etc. Conduct microbial based assays including bioburden testing, microbial quantification, and organism identification.
Essential Duties and Responsibilities
- Perform microbial and particulate monitoring of clean rooms throughout LA facility. Work under some Supervision. May be responsible for overseeing daily work flow of assigned area.
- Testing as required supporting microbial identifications, bioburden analysis, biological indicators, growth promotion, and water groups. Will be required to read microbial plates and interpret test results. Some troubleshooting will be required.
- Perform review of test data with application of GDP.
- Use Global LIMS or other computerized systems for entering and approving test results.
- Will be required to perform change requests (e.g. ECR, DCR) when required and complete them in a timely manner. Assure SOPs are updated; prepare and update as determined.
- Identification and issuance of Alert/OOL forms for out of limit results. May be required to conduct investigations into Alert/OOL excursions.
- Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines. Will be expected to do laboratory walk throughs to ensure area is suitable for hand off to oncoming shifts.
- Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
- Provide training and some work direction for assigned functional areas as required.
- Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner.
- Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
- Support execution of validations for lab equipment, lab methods, or facility projects.
- May be required to generate, execute, and summarize special laboratory studies.
- Drive Lean principles such as 5S throughout daily work activities.
- Ensure personal training requirements are met and that training records are current.
- May perform disposal of hazardous waste.
- Other duties as assigned by departmental management.
- Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
- Effective organizational skills and ability to plan and suggest resolutions to technical problems.
- Demonstrated working knowledge of assays/equipment in functional area.
- Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).
- Must be detail-oriented, conscientious, and responsible.
- Capable of applying some decisions-making to problem-solve technical, compliance, or operational problems, as assigned.
- Effective interpersonal communication. Must have effective verbal and written communication skills.
- Can demonstrate the ability to guide people, encourage teamwork, and teach assays.
- Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.
- Good project management skills a plus.
Must be able to learn new computer systems and programs in a timely manner.
Education and/or experience
Typically requires bachelor's degree in chemistry, biological science, or other related technical field. Some related work experience preferred.
- Must be able to lift, push, pull 25 lbs and carry up to 50 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will be working in a loud area that requires hearing protection and other protective equipment to be worn.
- 20/20 near vision required (corrected vision is acceptable).
- Will work in a cold, wet environment.
- Will work around chemicals such as alcohol, acids, and alkalines that require protective equipment.
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required (only for non-exempt positions).
- May be required to work in a confined area. Inside and Outdoor working conditions.
- Some Clean Room and cool/hot storage conditions.
- Perform removal of hazardous waste.
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.
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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.