Computer Systems Validation Engineer I

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
JOB SUMMARY
The CSV Validation Engineer I will support the CSV team in maintaining the systems/software in its most current validated state under supervision. The CSV Engineer I will ensure that all required Software/System Development Lifecycle Documents are available. Under supervision the CSV Engineer I will generate and execute validation documents including risk assessments, discrepancy management and reports; assist cross-functional team in identifying the required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipment. This position requires understanding and application of regulatory requirements - GxP, Annex 11, ICH Q7A, ASTM E2500 and GAMP.
JOB DUTIES

• Assist cross-functional teams in completing system/equipment impact assessments, electronic record and electronic signature assessments.
• Author and review validation documents (IQ/OQ/PQ) supporting GxP computerized systems, and relevant infrastructure, including system procurement, audit, performance, compliance evaluation, and validation.
• Ensure appropriate regulatory requirements are addressed in the validation protocols.
• Execute validation/test protocols, follow good documentation practices, support discrepancy/deviations investigations and corrective action identification
• Author Reports and Trace Matrices for the Computer Systems.
• Participate in the discrepancy/deviation review and closure.

PROFESSIONAL SKILLS

• Excellent written and oral communication to include accurate and legible documentation skills.
• Ability to work in a fast-paced environment. Team oriented. Independent work skills and a strong work ethic.
• Microsoft Office and database management skills.

EXPERIENCE

• At least 1+ years of relevant computer/computerized Systems Validation systems/software/equipment supporting GMP manufacturing operation and laboratory equipment/instruments in a Pharmaceutical or CDMO industry.
• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical industry a plus.

EDUCATION

• Associate/Bachelor's degree in Engineering, Computer Science or related discipline.

QUALITIES

• Thrives on learning
• Strong attention to detail. Understanding of group dynamics and teamwork
• Team oriented but able to work independently

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Must be able to sit or stand for prolonged periods of time
• Follows written instructions and can successfully manage multiple tasks

COMMUNICATIONS & CONTACTS

• Interacts with all departmental staff and other departments at all levels.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.