About the job
Fagron has an immediate opportunity for an experienced Software Validation Engineer to work under the direction of the Validation Director in an FDA-regulated environment. This position supports validation of Pharmaceutical Manufacturing Equipment Control Systems and Enterprise Resource Planning (ERP) applications.
The successful candidate will have the ability to work in a fast-pace pharmaceutical manufacturing environment, make decisions and is capable of setting and balancing priorities. Manage multiple projects with frequent changes and manage validation activities with cross-functional partners at all levels of the organization. Willingness to perform “hands on” work and manage consultants and contractors executing software validation activities throughout the facility. Provide technical expertise on Software Compliance standards and processes to team members; and input strategy to key business leaders.
Primary Responsibilities
- Developing an ERP validation plan and testing strategy in alignment with FDA regulations and industry-standard practices.
- Authoring computer system validation deliverables, including requirements specifications, testing protocols/scripts (i.e., IQ, OQ, PQ), validation incident reports, trace matrices, and validation reports.
- Working knowledge of FDA regulations (21 CFR 11, 21 CFR 820), FDA software validation guidelines, and GAMP software validation methodologies.
- Working directly with ERP software vendors, consultants, contractors and system owners.
- Understanding of validation concepts and requirements for manufacturing equipment control systems including Allen Bradley, Siemens, and PC based platforms.
- Validation of the ERP software packages used in pharmaceutical manufacturing, such as Microsoft AX, SAP, BPCS, NetSuite, SYSPRO etc.
- Authoring of SOPs for system use, administration, and change management.
- Able to independently organize and perform own work tasks.
- Able to work effectively with local, global, and virtual team members and other professionals, such as QA specialists, software developers, and system users.
- Proficiency with Microsoft applications, including Word and Excel.
Set yourself apart
You possess the following qualifications, background and abilities:
- AS, BS degree and/or equivalent experience in Computer Science, Software Engineering, or related discipline.
- 5 + years experiences with validation of computer systems.
- Experience working with regulatory agencies.
- General knowledge of the pharmaceutical industry, sterile compounding preferred.
- Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and industry best practices.
- This position may require 10-15% domestic and international travel.
Profile and Experience
- Experience with designing, managing, and programming and operating complex automated processes.
- Experienced leader, motivator, communicator and coach with a strong sense of working in a team environment.
- Excellent planning and organizational skills and ability to balance manufacturing and systems maintenance requirements.
- Proficient project manager and time manager with good communication, verbal, and writing skills.
- Understanding of Commissioning Qualification Validation (CQV) leveraging strategies.
- Experience in conducting and/or directing internal investigations of data integrity compliance issues.
- Ability to clearly disseminate written policies and procedures related to data integrity compliance requirements.
- Experience performing Data Integrity risk assessments and analysis.
- Ability to prioritize risk and work with IT, QA and other personnel to address Data Integrity gaps.
- An understanding of US and European regulations as related to Data Integrity.
Candidate Profile
- Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity.
- Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management).
- Knowledge of GMP including international regulations.
- Knowledge of applicable parts of 21 CFR regulations.
- Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.
- Good verbal and written communication skills
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.