Validation Specialist (Filling, Formulation) (s851)

  • Contract Duration: 3-6 months, with potential to extend
  • Manufacturing
  • Swiftwater, PA

Website Lenox Executive Search

The Validation Specialist will be responsible for generating/executing development / validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria. Typical processes being developed / validated include mixing, filling, formulation, visual inspection and lyophilization. Studies supporting these processes include hold time, mixing studies, filtration studies, CCIT, stability, Part 4 compliance.

• Formulation process development/validation
• Mixing development/validation
• Filling process development/validation
• Aseptic Processing experience
• Recent hands on experience executing process validations
• For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment (preferably with Swiftwater Lines 6, 7, 8 and/or 9) sufficient to identify process CPP’s and generate detailed validation protocol requirements and coordinate execution
• For formulation demonstrated experience with mixing, dispense and filtration process validation.
• Requires being on site an average of 2-3 days per week and more during executions.

• 5 to 7 years. Experience in, Process Validation (formulation, filling, visual inspection and/or lyophilization)
• GEODE access and experience in writing validation protocols and reports.
• Performance Qualification, E&L, CCIT and Part 4 compliance
• Familiarity with all aspects of filling lines including knowledge of filling formats and critical/key/controlled process parameters with direct experience in validating filling processes.
• Familiarity with Extractables/Leachable.
• Experience with SAP access for inventory lookup, warehouse ordering, material master/master recipe requests is a big plus.
• Experience with LIMS access for sample log in and results retrieval is very desirable.

– Skills, MS Office 365, Proficient in MS Word, Excel, Powerpoint and Outlook
– Electronic Documentation system (Geode preferred),
– Pharmaceutical Validation, Bio Pharma Validation, Validation execution,
– Technical writing abilities and good time management.
– Strong root cause analysis skills with cGMP experience.
– Ability to establish working relationships with other support and production areas in order to gather all of the necessary information required.
– Must be proficient in Geode with a working knowledge of templates, review workflows and approval process
– Interact well with a diverse group of individuals
– Self-motivated and willing to be proactive in resolving issues
– Excellent Verbal and written communication skills.
-Ability to work in a team environment.
-Ability to support development, clinical or validation activities on 2nd/3rd shift or weekends as needed.

– BS/MS in Engineering, Life Science or Physical Science


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