Manager of Validation

Founded in 1967, ALI Pharmaceutical Manufacturing (ALI-PM) manufactures and markets active pharmaceutical ingredients (APIs) for human prescription pharmaceuticals used to treat debilitating diseases.

At ALI-PM, we are looking for candidates with varied backgrounds and skills. Diverse ideas come from diverse people, and we are devoted to offering an all-encompassing work environment where everyone feels valued and respected. Our pace of work enables fast learning and fosters an environment where you can stretch yourself and make an impact. We offer a variety of job specific and business skills programs and trainings to our employees. As a member of our team, you will have an opportunity to draw from those resources when you need them, and likewise, contribute your expertise when you have something to share.

We offer a highly competitive compensation package (salary and bonus) as well as a comprehensive, family-friendly benefits package including:

• Exceptional family medical, dental, and vision benefits (100% company paid premiums). 100% paid deductible/out of pocket expenses for Medical
• Paid time off and sick leave
• 9 paid holidays
• Exceptional 401k fund contributions (up to 9%)
• Great schedules
• Wellness incentives

Pay is based on experience. Title may be adjusted based on experience. 

Take your career to the next level by applying today!

Manager of Validation

We have a career opportunity for a Manager of Validation. The Manager of Validation is responsible for the Validation department. As a Manager of Validation, you will be responsible for resourcing, coordinating and facilitating engineering projects with your team, from owning project assignments and progressing projects through the preliminary engineering phase into further stages.

The manager will be located at 4410 S 102nd St., working with different management levels and support personnel in other office locations.

The impact you will have:

• You will lead and manage the Validation department, including Technical Services employees and other personnel as determined on a project-to-project basis.
• You will oversee, manage, and support calibration programs for the facilities, including production equipment, facility equipment (boilers, HVAC systems, Water systems, etc.) and other instruments.
• You will generate, update, and approve Standard Operating Procedures (SOP) and Preventative Maintenance (PM) checklists, as well as write technical protocols and reports.
• You will report on performance outputs and project updates and communicate with diverse audiences of internal and external personnel.
• You will manage and support Change Control, Deviation and Corrective Action/Preventative Actions (CAPA) development, investigations, approval and implementation as assigned to the Validation department.

What we are looking for:

• Bachelor of Science in Engineering or related field (Master’s Degree preferred).
• Minimum of 5 years of Physical Facility, Maintenance, and/or Engineering experience with experience in FDA and cGMP environments.
• Experience with managing people, including conflict resolution, team building and development skills.
• Excellent time management and organization skills.
• Strong written and verbal communication and employee relation skills.
• Proficiency in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.