Recipharm is a leading contract development and manufacturing organization (CDMO) in the pharmaceutical industry employing 9,000 employees with headquarters in Sweden. One of Recipharm’s nine research and development facilities is in Research Triangle Park, North Carolina, USA. Recipharm Laboratories aspires to be the first-choice strategic partner for inhaled drug development companies worldwide.

We are seeking a Process Engineer to join us in our Inhalation department at Recipharm’s RTP, NC location. The level of the position will be based on qualifications and experience.

Key responsibilities will be:

• Identification, specification, procurement, and qualification of instrumentation and equipment to support the development and manufacturing of orally inhaled and nasal drug products including pressurized Metered Dose Inhalers (pMDI), soft mist inhalers (SMI), nasal sprays, and nebulized solutions. 
• Preparation of documentation (e.g. URS, SOPs, IQ/OQ protocols, etc.) associated with equipment procurement, qualification, and usage in a regulated cGMP environment. 
• Process design, including creation of process flow diagrams (PFDs), and hands-on setup of pilot-scale equipment to achieve desired objectives for customer-funded development projects. 
• Technical assessment of process risk using standardized methodologies (e.g. PHA, FMEA, etc.) and implementation of appropriate control strategies to minimize risk to operators. 
• Specify equipment calibration requirements, proactively identify appropriate preventative maintenance activities and spare parts, and lead process troubleshooting. 
• Continuous improvement of process development and manufacturing, with an emphasis on process safety, reliability, and efficiency. 
• Technology transfer of developed processes to manufacturing sites within Recipharm and external customers. 

Required Qualifications:

• BS degree in Chemical Engineering, Mechanical Engineering, or a related engineering field. 
• Four or more (4 ) years of relevant engineering experience in the pharmaceutical industry. 
• Experience with process design including equipment setup and qualification and hands-on execution of formulation development activities including manufacturing campaigns, equipment cleaning, cleaning verification/validation, etc.
• Familiarity with instrumentation and equipment used in the development and manufacturing of orally inhaled and/or nasal formulations (e.g. pressure vessels, pumps, mixers, homogenizers, filling equipment, pneumatic crimpers, etc.). 
• Thorough understanding of ICH, FDA, and other regulatory expectations for pharmaceutical product development and manufacturing. 
• Strong oral and written communication skills. 
• Self-motivated, and well organized with excellent time management abilities and problem-solving skills. 
• Experience in working both independently and in a team-oriented, collaborative environment. 

Preferred Qualifications:

• Experience with the development and manufacturing of orally inhaled and/or nasal drug products. 
• Experience working with and implementing controls for highly potent active pharmaceutical ingredients (HPAPIs), flammable liquids and gases, DEA controlled substances, etc.
• Understanding of Quality by Design (QbD) and/or Lean Six Sigma (LSS) and experience implementing elements of QbD/LSS into development and manufacturing operations. 
• Experience in a contract development and/or manufacturing organization (CDMO). 
• Creative thinking and problem-solving skills. 

Physical Requirements:

The Process Engineer must possess the ability to stand and/or walk for up to 8 hours a day and carry up to 25 pounds. This position involves repetitive motion of the arm, wrist, hand and fingers with the ability to feel and handle work materials for up to 8 hours per day. The position also requires the ability to carry out tasks involving extensive reaching, crouching, and bending. Day to day tasks may involve handling of and the ability to identify hazardous chemicals and materials.

We offer a competitive compensation and benefits package including:Full Benefits (Medical, Dental, Vision, Life, Disability)401(K) with Company MatchPaid Vacation & Sick Time

Dependent Care FSA

Educational reimbursement program

**Relocation assistance is not provided for this position. Candidate must be able to commute daily to the job site**

COVID-19 considerations:Vaccinations strongly recommended for all adults.