Business Systems Analyst, Comp Systems - Boehringer Ingelheim
Fremont, CA
About the Job
Description
The Business Systems Analyst, Comp Systems is responsible for maintaining systems (LIMS, MES, Track & Trace, and other systems) in support of Quality and Manufacturing and assisting with implementing enhancements or new systems. Systems contain the core functionality, additional modules, and key interfaces (i.e., Empower 3). This may include identifying and implementing business process improvements that will drive Fremont's business performance and Quality innovation.
The incumbent provides Subject Matter Expert (SME) technical expertise on the following areas:
+ Provides a high level of independent judgment and discretion in the timely identification, investigation, and resolution of issues impacting Quality and Manufacturing department.
+ Oversight responsibilities include ensuring adherence to cGMP requirements, proper change control, corrective action and preventative action plans, impact assessments for changes to equipment and processes, risk management, ensure documentation and investigations meet BIFI and regulatory standards.
+ Works with autonomy and authority.
+ Leads and assists in implementing continuous improvement efforts as it relates to Quality and Manufacturing activities.
+ Fosters quality collaboration among Quality and Manufacturing staff.
The Business Systems Analyst, Comp Systems ensures programs and processes are aligned with Corporate/Global BioPharm and maintained in accordance with cGMP/Quality/Compliance regulations.
Duties & Responsibilities
+ Responsible for maintaining systems (QC, Stability, Environmental Monitoring, MES) at BI Fremont.
+ May assist with the implementation of enhancements or new systems.
+ Engages network to ensure alignment with Corporate/Global BioPharma sites and operating units.
+ May be a delegate for the process during internal/ corporate client audits and health authority inspections.
+ Responsible for training site staff involved with the systems. May be the key point of contact when working with internal partners (E&T, Validation, QA) and external partners (vendors).
+ Assists and acts as a delegate for SME for Data Integrity initiatives, continuous improvements, and related activities.
+ Assists in cross-functional investigations or assessments in support of change controls, CAPA/ investigations, or other compliance activities as it relates to systems.
+ Manages moderate to complex projects to ensure deliverables are met on time.
+ Applies project management experience and concepts to when working within QC teams and cross functional teams.
+ Assists in validation activities as it relates to systems; may include development and validation of interfaces or new reports.
+ May develop validation protocols using a risk-based approach that meets current regulatory requirements and industry practices, with oversight from the Validation and QA.
Requirements
+ Bachelor's Degree in Biopharmaceuticals, Chemistry, or Biology (or closely related degree).
+ Requires three (3) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas. Strong independent judgment and decision-making abilities required.
+ Minimum of three (3) years systems experience (Development, Validation, Maintenance)
+ Excellent technical writing, verbal communication skills, and good interpersonal skills.
+ Experience in interpreting and relating Validation standards for implementation and review to functional areas.
+ Knowledge and experience with implementing 21 CFR Part 11 and Annex 11 compliant instruments and software.
+ Independent decision-making capability and ability to think conceptually and understand impact of decisions critical, strong conflict resolution and negotiation skills.
+ Able to influence strategy and think strategically.
+ Good knowledge of validation of new computer systems, changes to existing computer systems, and/or decommissioning computer systems; includes experience with system life cycle documents.
+ Completion of systems (LIMS, MES, SAP) certification.
+ Knowledge of the following Software: Empower CDS, SoftMax Pro, 32 Karat, ChemStation, Biacore T200, DataPro2 preferable.
+ Experience with Data Integrity and continuous improvement (data mapping, gap assessments, remediation).
+ Experience leading projects with history of achieving results and outstanding outcomes.
+ Good working knowledge of relevant regulations and guidance required to act as a resource for colleagues. Including but not limited to 21 CFR Part 11 and Annex 11.
+ Project management experience with the ability to manage multiple projects against given timelines is preferable.
+ Provide support managing technical projects with an interdisciplinary project team, from planning to realization and start up.
+ Ability to work as part of a high performing team and collaborate effectively with staff at all levels.
+ Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
+ Must have a experience in the application of validation principles.
+ Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
+ Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio.
+ Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
Eligibility Requirements :
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
Compensation Data
This position offers a base salary typically between (83,000) and (162,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
The Business Systems Analyst, Comp Systems is responsible for maintaining systems (LIMS, MES, Track & Trace, and other systems) in support of Quality and Manufacturing and assisting with implementing enhancements or new systems. Systems contain the core functionality, additional modules, and key interfaces (i.e., Empower 3). This may include identifying and implementing business process improvements that will drive Fremont's business performance and Quality innovation.
The incumbent provides Subject Matter Expert (SME) technical expertise on the following areas:
+ Provides a high level of independent judgment and discretion in the timely identification, investigation, and resolution of issues impacting Quality and Manufacturing department.
+ Oversight responsibilities include ensuring adherence to cGMP requirements, proper change control, corrective action and preventative action plans, impact assessments for changes to equipment and processes, risk management, ensure documentation and investigations meet BIFI and regulatory standards.
+ Works with autonomy and authority.
+ Leads and assists in implementing continuous improvement efforts as it relates to Quality and Manufacturing activities.
+ Fosters quality collaboration among Quality and Manufacturing staff.
The Business Systems Analyst, Comp Systems ensures programs and processes are aligned with Corporate/Global BioPharm and maintained in accordance with cGMP/Quality/Compliance regulations.
Duties & Responsibilities
+ Responsible for maintaining systems (QC, Stability, Environmental Monitoring, MES) at BI Fremont.
+ May assist with the implementation of enhancements or new systems.
+ Engages network to ensure alignment with Corporate/Global BioPharma sites and operating units.
+ May be a delegate for the process during internal/ corporate client audits and health authority inspections.
+ Responsible for training site staff involved with the systems. May be the key point of contact when working with internal partners (E&T, Validation, QA) and external partners (vendors).
+ Assists and acts as a delegate for SME for Data Integrity initiatives, continuous improvements, and related activities.
+ Assists in cross-functional investigations or assessments in support of change controls, CAPA/ investigations, or other compliance activities as it relates to systems.
+ Manages moderate to complex projects to ensure deliverables are met on time.
+ Applies project management experience and concepts to when working within QC teams and cross functional teams.
+ Assists in validation activities as it relates to systems; may include development and validation of interfaces or new reports.
+ May develop validation protocols using a risk-based approach that meets current regulatory requirements and industry practices, with oversight from the Validation and QA.
Requirements
+ Bachelor's Degree in Biopharmaceuticals, Chemistry, or Biology (or closely related degree).
+ Requires three (3) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas. Strong independent judgment and decision-making abilities required.
+ Minimum of three (3) years systems experience (Development, Validation, Maintenance)
+ Excellent technical writing, verbal communication skills, and good interpersonal skills.
+ Experience in interpreting and relating Validation standards for implementation and review to functional areas.
+ Knowledge and experience with implementing 21 CFR Part 11 and Annex 11 compliant instruments and software.
+ Independent decision-making capability and ability to think conceptually and understand impact of decisions critical, strong conflict resolution and negotiation skills.
+ Able to influence strategy and think strategically.
+ Good knowledge of validation of new computer systems, changes to existing computer systems, and/or decommissioning computer systems; includes experience with system life cycle documents.
+ Completion of systems (LIMS, MES, SAP) certification.
+ Knowledge of the following Software: Empower CDS, SoftMax Pro, 32 Karat, ChemStation, Biacore T200, DataPro2 preferable.
+ Experience with Data Integrity and continuous improvement (data mapping, gap assessments, remediation).
+ Experience leading projects with history of achieving results and outstanding outcomes.
+ Good working knowledge of relevant regulations and guidance required to act as a resource for colleagues. Including but not limited to 21 CFR Part 11 and Annex 11.
+ Project management experience with the ability to manage multiple projects against given timelines is preferable.
+ Provide support managing technical projects with an interdisciplinary project team, from planning to realization and start up.
+ Ability to work as part of a high performing team and collaborate effectively with staff at all levels.
+ Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
+ Must have a experience in the application of validation principles.
+ Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
+ Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio.
+ Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
Eligibility Requirements :
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
Compensation Data
This position offers a base salary typically between (83,000) and (162,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim
