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CAREERS

Join our winning team! We are passionate; smart; deliberate; focused; committed; driven. These six personality traits describe our team in a nutshell and drive how we conduct our business.

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EMPLOYMENT NEEDS

Project Manager

Manage, lead and deliver Company Services across the various business and technical areas including Project Management, Business Development, Sales and Marketing, Quality Systems, and Compliance. Provide Project Management support at our client sites by either leading or supporting a team.

Job responsibilities include:

  • Project Management and Delivery
  • Technical and Scientific Management
  • Business Development
  • Sales and Marketing
  • Business Management

To read the full Job Description, click HERE.

To apply directly, click HERE.

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General Inquiries

We offer an entrepreneurial environment conducive to risk-taking, innovative contribution and ingenuity. We offer a strong total rewards package and financial incentives for exceptional performance and overall company results.

We are always looking to employ qualified, highly skilled and talented professionals who will contribute to our collective success for both internal and external business operations. This is who we are and this is where bright futures begin. If you feel you would be a good fit for our team, please submit your application and resume HERE.

 

CONTRACT NEEDS

Process / Equipment Validation Specialist

Bachelor’s degree in engineering, science, or similar. Candidate must have a minimum of 5-8 years of experience with qualification, protocol generation and execution in FDA-regulated companies. Responsibilities will require performing manufacturing process and equipment qualification activities for a global oral solid dosage pharmaceutical company.

  • Knowledge and understanding of Pharmaceutical GxPs and excellent GMP documentation skills
  • Must be high energy, self-directed and driven, and must be able to work independently or with little supervision with sense of urgency accomplishing each task assigned
  • Ability to effectively interact with individuals at all levels
  • Intermediate to advanced MS Word and Excel needed as well as TrackWise, SharePoint, and PDF creator software experience
  • Excellent written and verbal communication skills

To apply directly, click HERE.

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SOP Technical Writer

Bachelor’s Degree in the Life Sciences or Engineering field, or similar with 2-5 years of GMP experience with expertise in authoring fundamental Quality System SOPs for an FDA regulated company.

  • Experience drafting new SOPs and editing existing SOPs to align with current practices
  • Excellent writing and oral communication skills
  • Ability to exercise judgment within defined procedures and practices to determine appropriate action with minimal supervision
  • Maintain standardized language and documentation that allow for consistent execution of documents
  • Advanced MS office skills including Word
  • Well organized and detail oriented with the ability to handle multiple tasks

To apply directly, click HERE.

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Technical Writer

Minimum of Bachelor's Degree in Science or Engineering, or related. Role will require focused expertise in sterile operations, quality and laboratory controls to improve SOPs associated with CAPAs and to initiate Change Controls, as applicable.

  • Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
  • Strong writing aptitude and ability to review technical documents
  • Review proposed changes that might affect validated or controlled status of manufacturing practices
  • Draft SOPs in response to CAPAs and initiate the associated change controls

To apply directly, click HERE.

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Validation Engineer

Minimum of 4-5 years of experience of commissioning and validating equipment and field execution. Must have a degree in engineering, science, or similar.

  • Knowledge and understanding in developing Validation Master Plans (VMP), Validation Protocols, and Final Reports
  • Experience with facility, utility, equipment, and process validation
  • Proficient technical writer with excellent written, verbal and interpersonal skills, along with proficiency in MS Office (particularly MS Word and Excel)
  • Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
  • Ability to communicate with Manufacturing personnel and handle equipment change needs while managing multiple projects / priorities simultaneously

To apply directly, click HERE.

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