Columbus, OH, US
15 days ago
Empower / LIMS Application Specialist

Job Title: Technical Engineer, Empower/LIMS
Location: Columbus, OH or Cherry Hill, NJ
Job Type: Full-Time
Req ID: 6270

 

About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Software Engineer, IT Applications- QRLS to join our team.  In this role, you will partner with IT team members and the client community to deliver IT Quality services and solutions in support of business objectives to improve productivity.  Activities include analysis, interpretation, identifying trends, application monitoring, ongoing system maintenance, and addressing corrective actions. Responsibilities include baseline IT process review, application support, participation and leadership on project teams, system and process optimization, vendor management and technology consulting.

 

Key Responsibilities:
•  Requires full-time onsite attendance.

•  Responsible for design, architecture and implementation of applications and application components in the Quality environment specifically for Waters Empower chromatography solution and/or LabWare LIMS following the defined process framework of complex systems and software.

•  Responsible to provide application maintenance, optimization, innovation and manage 3rd level support for implemented and/or assigned solutions. Troubleshooting system problems that have been escalated.

•  Support Service goals by participating on or leading project teams. Deliver on assigned tasks and action items.

•  Serve as an expert for existing applications or solutions on a technical level for both business and regulatory agencies.  Employ comprehensive knowledge to influence technologies and solution decisions.

•  Identify IT or Pharma industry processes or technologies that could provide a competitive advantage.

•  Participate in both internal and external audits to address application questions as needed.  These audits can involve the DEA, FDA, or other government regulatory groups, and internal audits

•  Understand the IT and company framework and follow defined processes. Determine documentation requirements and produce documentation as required in support of baseline and project activities including SLC documents (e.g. URS, FS, DS). Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.

•  Act according to valid quality and compliance regulations


Qualifications: We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: 

 B.S/B.A., preferably in a Computer Science-related discipline, with minimum of 2 years' relevant pharmaceuticalusiness or IT experience such as major system administration; or Associates degree, preferably in a Computer Science-related discipline, with 4 years relevant pharmaceutical business or IT experience; or, High school diploma or equivalent with 6 years relevant pharmaceutical business or IT experience with quality applications.  Experience as key member of a project team preferably in computer application development projects. Demonstrated troubleshooting ability for both the computer application and laboratory instrument interfaces Proficiency in Microsoft Office Suite tools (Outlook, Word, Excel) Direct and intimate knowledge of applicable laws and regulations including those mandated by FDA, DEA, EMEA Good understanding of team support especially on a global scale Ability to effectively manage and partner with team members Must have excellent communication skills, both written and verbal, especially with verbal interactions with regulatory agencies Must be able to work independently Must possess strong time management skills

 

Preferred Qualifications:
•    Waters Empower and/or LabWare LIMS administration ability

•    Ability to provide off-hours support

•    Knowledge and/or experience Veeva QualityDocs, Veeva QMS, or Veeva RIMS a plus

 

What We Offer*:

Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave

 

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

 

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

 

Agency Notice:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

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