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Drug Process Engineer

Location

Longmont, CO, USA

Department

Engineering

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Position Title: Drug Process Engineer I
Job Location(s): Longmont, CO
Start Date: ASAP
Employment Type: Full-Time
Starting Salary Range: Competitive
Job requisition #: 18169

DUTIES:

The position will be responsible for coordinating projects through the Drug Product manufacturing area working with multiple departments to ensure projects are executed on time.  Responsible for the conducting demonstration/notebook batch production and creation of cGMP manufacturing batch records to introduce early phase drug product into the 2600 Drug Product Facility.  The ideal candidate will have experience in the formulation, optimization and scale-up of solid dose drug product.  Experience working with cGMP and quality systems, SOP preparation, report writing, equipment qualification and knowledge of FDA, EU, and ICH requirements and their implementation in the pharmaceutical industry.

RESPONSIBILITIES:

  • As a Drug Process Engineer you will coordinate the execution of notebook and GMP batches through the drug product facility.  This entails ensuring materials and equipment are available, resources are aligned and paperwork is in order.
  • You will Lead the process development and implementation of cGMP manufacturing documents for projects.
  • You will be responsible for writing and execution of demonstration/notebook batches, batch records, writing NCMRs and writing of development/process reports.
  • You will be responsible for ordering supplies, materials for projects, and purchasing equipment and parts for the drug product facility.
  • You will be responsible for SAP updates and execution of products in SAP.
  • You will support the shipping of Drug Product to clients.
  • You will be called upon to support problem solving of technical issues pertaining to drug product manufacturing.
  • You will be responsible for bringing in new equipment as needed for projects and support and execute the qualification for specific equipment.  This entails change control initiation and closure, SOP writing and equipment qualification execution.
  • You will support the development of manufacturing process trains of drug product.
  • You will support the creation technical documents and reports.
  • You will be responsible for attending client meetings and interacting with clients pertaining to drug product manufacturing.
  • Additionally, you will adhere to all applicable procedures, cGMPs, company policies, and any other quality or regulatory requirements.  (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.).

QUALIFICATIONS:

  • Bachelor’s Degree with 0-2 years of applicable experience.  Chemical Engineering degree a PLUS.
  • Experience in ORAL SOLID DOSE drug product formulation and process development required.
  • Experience interfacing with external customers
  • Experience in CDMO industry preferred.
  • Knowledge of FDA, EU, and ICH requirements and their implementation in the pharmaceutical industry required.
  • Experience in establishing experimentation and cGMP documents for the manufacture of drug product.

SUCCESS FACTORS:
This person must also have strong interpersonal skills, demonstrated scientific skills, excellent written and verbal communication skills, and leadership abilities.

As a team player, this individual will be self-motivated, flexible when working with teams, and enthusiastic about drug product process optimization and scale-up.

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status