Provide hands-on end user support, administration, installation and issue resolution for GxP controlled laboratory equipment, servers, desktops and software packages. Perform laboratory upgrades (software, desktop components, etc), create system documentation and author/execute test scripts as needed. Broad knowledge of QC analytical instrument applications, computer architecture, validation strategies, and applicable regulations. Lead, plan, design, direct and evaluate improvement, and compliance projects in the Quality Control Laboratories with focus on computerized systems and applications.
Essential Duties and Responsibilities
- Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.
- Perform laboratory equipment, hardware and software upgrades following corporate computer system validation policy and GMP best practices.
- Responsible for setting/maintaining the computerized systems framework for analytical instruments in the QC environment, including applicable enterprise systems; serve as system administrator for applicable computerized systems as needed
- Coordinate with users and vendors to facilitate timely resolution of software / hardware issues.
- Execute routine system administration and maintenance activities as required.
- Create and/or execute software validation scripts to support laboratory.
- Create and maintain system documentation including system design specifications, user requirements, functional requirements or routine controlled application change forms.
- Responsible for the evaluation of new or updated applications. Provide recommendations for instrumentation/applications purchases and upgrades to drive optimal performance.
- Lead and responsible for projects in the design, execution, and data analysis in laboratory analytical equipment qualification and computerized systems improvements in the QC laboratories. Apply and correlate application improvements with analytical methods when appropriate. Ensure completion of all protocols and validations in a timely and appropriate manner. Report progress and impact of results to laboratory management and/or project leaders. Recommend utilization of results or changes in the scope of work (including termination of project)
- Serve as the 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 documentation 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). Serve as a technical expert and interface with inspectors during both internal and external inspections.
- Support and change requests related to computerized systems and/or software installations and ensure actions are executed properly and in a timely manner when required.
- Proactively lead and/or 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 technical presentations and/or training to QM Laboratories (including management) as needed.
- Ensure personal training requirements are met and training records are current.
- Stay current in the technical and compliance field regarding lab instruments and methods.
- Must have the ability to troubleshoot complex problems involving multiple technologies and develop solutions.
- Must demonstrate strong leadership, influence, and cross-functional collaboration skills.
- Must exhibit sound decision-making ability and strong interpersonal skills.
- Must be able to effectively communicate (both verbal and written) with subordinates, peers, and managers.
- Excellent project management, organizational, and time management skills are a must. Ability to manage multiple projects concurrently and ensure they are completed in a timely manner.
- Proficient in a wide variety of lab application software and enterprise systems (e.g. Empower, OpenLab, LIMS and CDS).
- Ability to prioritize and thrive in a fast-paced environment.
- Able to effectively problem solve laboratory testing procedures and troubleshoot lab equipment.
- Ability to analyze complex data and present analysis/outcomes to management.
- Capable of performing advanced trending and navigating statistical software.
- Demonstrate good technical writing skills. Able to write effective technical documents.
- Knowledgeable and proficient in statistical analysis, quality systems (e.g. change control, exception management, CAPA, audit processes, validation, etc.) and interpretation of cGMP, CFR, USP, JP, EP and GDP.
- Knowledge of government regulations pertaining to pharmaceutical and medical device manufacturing laboratories.
- Demonstrate effectiveness in ability to train others, encourage empowerment, and drive completion of project and/or milestone commitments.
- Familiarity in leading and driving principles of continuous improvement and DMAIC problem-solving methods.
- 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 6+ years of related experience or bachelors' degree in information technology or related technical field and 4+ years of related experience. Pharmaceutical/biopharmaceutical laboratory industry experience preferred. Qualified candidate must have demonstrated knowledge of server / application administration, laboratory equipment, network concepts, and GMP validation best practices. Experience with Citrix administration, database administration, application development / scripting 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 cool/hot storage conditions as necessary.
- 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.
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.