Validation Specialist

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Validation Specialist

Alcami Corporation

icon Hatfield, PA, US, 19440

iconFull Time

icon10 July 2024

Job Expired

ATTENTION JOB SEEKERS!

BE PART OF AN ORGANIZATION WORKING WITH COMPANIES WHO ARE FINDING CURES AND TRANSFORMING MEDICINE!

Full-time hourly position - competitive salaries, career advancement opportunities, a bonus plan, excellent benefits package including a matching 401K, health, dental, vision and tuition reimbursement.

Full-time and hourly positions - competitive salaries, career advancement opportunities, a bonus plan, excellent benefits package including a matching 401K, health, dental, vision and tuition reimbursement. 

Job Summary:

Responsibilities for this position involve validation equipment operation, protocol development, protocol execution and associated activities.This position will support a wide range of validation activities, including laboratory and manufacturing equipment of all types, laboratory and manufacturing technical support services, facilities/utilities, computerized systems and data integrity assessment/remediation.

This full-time position works with supervision to gain experience with more experienced staff.

This position is for day shift but may require some occasional off shift overnight and/or weekend coverage to accommodate schedules and/or project timelines.

Essential Duties and Responsibilities:

  • Directly support validation projects at external client sites
  • Operate validation test equipment: process meter, data logging systems
  • Independently develop and execute validation protocols and procedures
  • Perform CSV (computer software validation) and data integrity assessment/remediation
  • Support deviation resolution and troubleshooting strategies with client
  • Provide technical support to laboratory and/or manufacturing areas
  • Support positive client interaction and communication
  • All other duties as assigned

Education, Experience and Qualifications:

  • BA/BS in technical or science field of study. Candidates with an HSD/GED, technical training, or an Associate’s degree combined with mechanical aptitude or relevant industry experience
  • Strong working knowledge of IT concepts, strategies, and methodologies
  • Proficient with Microsoft Office (Word Excel, Powerpoint)
  • Strong written and verbal communication skills
  • Strong mechanical skills
  • Strong reporting, organizational and interpersonal skills
  • Ability to multitask and to perform tasks with high quality and accuracy
  • Validation experience or experience working in a GMP regulated environment is a plus, including working knowledge of ISO 9001, ISO 17025, GMP, GLP, GAMP 5 and 21 CFR Part 11

Additional Information:

  • Drug testing
  • Inoculations specific to customer sites
  • Travel required
  • Valid driver’s license