Provides hands-on end user support, administration, installation and issue resolution for GxP controlled laboratory equipment, servers, desktops and software packages. Support laboratory upgrades (software, desktop components, etc), assist in creation of system documentations and execute test scripts as needed. Broad knowledge of QC analytical instrument applications, computer architecture, validation strategies, and applicable regulations. Execute improvement, and compliance projects in the Quality Control Laboratories with focus on computerized systems and applications.
Essential Duties and Responsibilities:
- Ability to administer multiple applications which covers user, permission and roles management, backups, archival, audit trail and other application related configurations.
- Troubleshoot and resolve complex computer laboratory technical issues involving software, OS, hardware, network, peripherals and scientific equipment setup/interfaces.
- Perform laboratory equipment, hardware and software upgrades following corporate computer system validation policy and GMP practices.
- Assist in setting/maintaining the computerized systems framework for analytical instruments in the QC environment, including applicable enterprise systems; serve as primary or backup system administrator for applicable computerized applications as needed.
- Coordinate with users and vendors to facilitate timely resolution of software/hardware issues.
- Execute routine system administration and maintenance activities as required.
- Execute routine and periodic system verification's such as backup and archive restoration and verification.
- Create and/or execute software validation activities to support laboratory.
- Assist in Data Integrity related programs that impact computer applications and systems.
- Create and maintain system documentations including system design specifications, user requirements, functional requirements or routine controlled application change forms.
- Serve as secondary subject matter expert and provide technical support to the QC Laboratories for computerized systems and software. Identify and provide resolution to equipment/software application related issues. Provide expert advice to teams involved in the troubleshooting and problem-solving activities.
- Comply with control of lab documentation. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR and cGMP regulations.
- Write technical memos, reports, protocols, studies and other appropriate documentations to support laboratory objectives.
- Assure compliance with company procedures, quality and regulatory requirements, and regulatory guidance documents including QSR, cGMP, USP, CFR, and compendia literature. Develop and implement laboratory systems and/or guidelines to meet compliance requirements.
- Prepare for regulatory and non-regulatory audits (e.g Internal Quality Assessment, Corporate, FDA, etc).
- Support change requests related to computerized systems and/or software installations and ensure actions are executed properly and in a timely manner when required.
- Embrace and demonstrate Quality Culture.
- Ensure personal training requirements are met and training records are current.
- Must have the ability to troubleshoot complex problems involving multiple technologies and develop solutions.
- Must exhibit sound decision-making ability and strong interpersonal skills.
- Ability to prioritize and thrive in a fast-paced environment.
- Demonstrate good technical writing skills. Able to write effective technical documents.
- Knowledge of government regulations pertaining to pharmaceutical and medical device manufacturing laboratories.
- Skilled in use of electronic word processing, spreadsheet, project management and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).
Education and/or Experience:
- High school diploma or GED plus 3+ years of related experience or bachelors' degree in information technology or related technical field and some related experience.
- Qualified candidates must have demonstrated knowledge of application administration, server, network and database concepts, and GMP validation best practices.
- Experience with SQL Server, Oracle or any standard SQL based database administration and programming is a plus.
- Must be able to lift, push, pull and carry up to 25 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 work around chemicals such as alcohol, acids, buffers, etc in a laboratory environment.
- Must be able to work multiple shifts, including weekends to meet business needs.
- Must be able to work supplemental hours as necessary to complete work commitments.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- 5% travel, as applicable.
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.