Almac Group
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Validation Specialist
role at
Almac Group .
This role is located in Audubon, PA and you will be responsible for managing validation activities within Almac Pharma Services to ensure compliance with regulatory requirements and industry standards.
Responsibilities
Actively manage and be involved in the execution of all stages of the validation life-cycle.
Develop project design documentation.
Generate validation plans for larger projects.
Plan, prepare and execute equipment and process validation protocols and reports in support of the site’s validation program.
Liaise with non‑Pharma Services personnel (manufacturers, suppliers, clients and external validation/qualification resources).
Compile validation protocols and reports.
Collate and analyze process validation data.
Witness certain validation activities.
Support the Validation and Quality teams with onboarding of new projects and assets.
Coordinate project activities, timelines and schedules.
Work with clients and Project Management teams to understand client and project requirements and develop project‑specific tasks and timelines.
Manage and complete the periodic re‑evaluation and re‑qualification of equipment and systems (Production and Laboratory) as determined by re‑qualification and periodic review schedules.
Qualifications Required Experience / Education:
Bachelor’s Degree.
1 year of experience in a technical or scientific environment or internship in a technical or scientific area.
Preferred Experience:
Contract packaging experience.
Continuous Improvement.
Experience with Capitol Facility projects and/or Ultra Low temperature packaging processes.
Serialization systems, preferably Optel systems.
Temperature mapping.
Proof of concept process mapping for temperature‑controlled products.
Experience with packaging equipment: blistering, bottling, carding, labeling, pouching, autoinjector and/or syringe assembly preferred.
3+ years experience working in a cGMP environment.
Required Knowledge:
Knowledge of regulatory requirements and industry standards for validation of pharmaceutical packaging equipment, processes and cleaning.
Thorough knowledge of and proven experience in a validation or engineering role within the clinical, pharmaceutical, or R&D environment.
Preferred Knowledge:
Risk Assessment and Management.
Data Integrity regulations.
What Almac Group can offer you
Medical, Vision & Dental benefits from the 1st of the month following start date.
20 days PTO per year, accrued monthly following start date.
12 holidays per year.
Company paid Long and Short‑term disability along with Life Insurance.
401k company contribution.
Hybrid work available for applicable roles.
Professional development programs/ continuous learning opportunities.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
EEO is the Law.
EEO is the Law GINA Supplement.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
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Validation Specialist
role at
Almac Group .
This role is located in Audubon, PA and you will be responsible for managing validation activities within Almac Pharma Services to ensure compliance with regulatory requirements and industry standards.
Responsibilities
Actively manage and be involved in the execution of all stages of the validation life-cycle.
Develop project design documentation.
Generate validation plans for larger projects.
Plan, prepare and execute equipment and process validation protocols and reports in support of the site’s validation program.
Liaise with non‑Pharma Services personnel (manufacturers, suppliers, clients and external validation/qualification resources).
Compile validation protocols and reports.
Collate and analyze process validation data.
Witness certain validation activities.
Support the Validation and Quality teams with onboarding of new projects and assets.
Coordinate project activities, timelines and schedules.
Work with clients and Project Management teams to understand client and project requirements and develop project‑specific tasks and timelines.
Manage and complete the periodic re‑evaluation and re‑qualification of equipment and systems (Production and Laboratory) as determined by re‑qualification and periodic review schedules.
Qualifications Required Experience / Education:
Bachelor’s Degree.
1 year of experience in a technical or scientific environment or internship in a technical or scientific area.
Preferred Experience:
Contract packaging experience.
Continuous Improvement.
Experience with Capitol Facility projects and/or Ultra Low temperature packaging processes.
Serialization systems, preferably Optel systems.
Temperature mapping.
Proof of concept process mapping for temperature‑controlled products.
Experience with packaging equipment: blistering, bottling, carding, labeling, pouching, autoinjector and/or syringe assembly preferred.
3+ years experience working in a cGMP environment.
Required Knowledge:
Knowledge of regulatory requirements and industry standards for validation of pharmaceutical packaging equipment, processes and cleaning.
Thorough knowledge of and proven experience in a validation or engineering role within the clinical, pharmaceutical, or R&D environment.
Preferred Knowledge:
Risk Assessment and Management.
Data Integrity regulations.
What Almac Group can offer you
Medical, Vision & Dental benefits from the 1st of the month following start date.
20 days PTO per year, accrued monthly following start date.
12 holidays per year.
Company paid Long and Short‑term disability along with Life Insurance.
401k company contribution.
Hybrid work available for applicable roles.
Professional development programs/ continuous learning opportunities.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
EEO is the Law.
EEO is the Law GINA Supplement.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
#J-18808-Ljbffr