ALMAC Group
Almac Group is currently seeking a
Validation Specialist
for our
Audubon Pa
location. The Validation Specialist is responsible for managing validation activities within Almac Pharma Services to ensure that all critical facilities, utilities, systems and processes remain in compliance with applicable regulatory requirements and industry standards.
Responsibilities
Actively manage and be involved in the execution of all stages of the validation life-cycle, including development of project design documentation and generating 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 (including 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 Validations 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 requalification of equipment and systems (Production and Laboratory) as determined by requalification and periodic review schedules.
Qualifications
Required Experience / Education:
Bachelor\'s Degree; 1 year experience in a technical or scientific environment or internship in a technical or scientific area.
Preferred Experience:
Contract packaging experience; Continuous Improvement; 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 equipment, bottling, carding, labeling, pouching, autoinjector and/or syringe assembly (preferred); 3+ years\' experience working in a cGMP environment.
Required Knowledge:
Knowledge of the regulatory requirements and industry standards for validation of pharmaceutical packaging equipment, processes and cleaning; thorough knowledge of and proven experience in validation or engineering role within the clinical, pharmaceutical, or R&D environment.
Preferred Knowledge:
Risk Assessment and Management; Data Integrity regulations.
What can Almac Group 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 is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. "Partnering to Advance Human Health" is more than just a tagline - it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group\'s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CVs not submitted through our portal or directly to Hiring Managers will be considered unsolicited, and no fee will be payable. Thank you for your cooperation.
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
for our
Audubon Pa
location. The Validation Specialist is responsible for managing validation activities within Almac Pharma Services to ensure that all critical facilities, utilities, systems and processes remain in compliance with applicable regulatory requirements and industry standards.
Responsibilities
Actively manage and be involved in the execution of all stages of the validation life-cycle, including development of project design documentation and generating 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 (including 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 Validations 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 requalification of equipment and systems (Production and Laboratory) as determined by requalification and periodic review schedules.
Qualifications
Required Experience / Education:
Bachelor\'s Degree; 1 year experience in a technical or scientific environment or internship in a technical or scientific area.
Preferred Experience:
Contract packaging experience; Continuous Improvement; 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 equipment, bottling, carding, labeling, pouching, autoinjector and/or syringe assembly (preferred); 3+ years\' experience working in a cGMP environment.
Required Knowledge:
Knowledge of the regulatory requirements and industry standards for validation of pharmaceutical packaging equipment, processes and cleaning; thorough knowledge of and proven experience in validation or engineering role within the clinical, pharmaceutical, or R&D environment.
Preferred Knowledge:
Risk Assessment and Management; Data Integrity regulations.
What can Almac Group 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 is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. "Partnering to Advance Human Health" is more than just a tagline - it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group\'s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CVs not submitted through our portal or directly to Hiring Managers will be considered unsolicited, and no fee will be payable. Thank you for your cooperation.
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