Process Engineer

Job Description

Job Description

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package. This position is eligible for hybrid schedule once fully proficient in role.

I. Position Overview:

The position is responsible for interfacing with Operations, Quality, Engineering, and Product Development to identify and implement robust solutions that realize efficiencies, enhance capability, and reduce overall execution costs.

II. Specific Duties, Activities, and Responsibilities:

• Lead approved projects and drive to completion while maintaining project timelines and budget objectives for small to medium projects.
• Collaborate with cross-functional teams that identify, evaluate, develop, and implement process improvements to drive operational excellence, process reliability, based on supporting data, technical knowledge, engineering principles, and current good manufacturing practices (cGMP’s).
• Collaborate on the design of process equipment. Assist vendors during install and commissioning of new process equipment. Review engineering specifications for the various facets of the process integration including, pneumatics, electronics, controls, etc.
• Participate in investigations to identify root causes for process discrepancies or out-of-specification (OOS) test results to identify and implement effective corrective and/or preventive actions (CAPA’s) to ensure product quality and customer safety is maintained or enhanced throughout the site.
• Utilize good engineering practices and change management systems to document equipment commissioning, qualification and change history. Author and execute engineering studies to support process design, development, investigation and improvement using experimental design and statistical analysis principles.
• Evaluate and improve process controls to ensure reliable and repeatable manufacturing processes by updating critical instrumentation systems, process drawings, manufacturing instructions and procedures. Identify and understand control strategy between Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)).
• Proficient in the Blow Fill Seal manufacturing process including compounding, filling and packaging. Demonstrate aseptic technique and sterility assurance requirements.
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

III. Position Requirements:

Education or Equivalent:

• Bachelor of Science degree in Engineering/chemistry/Pharmacy or other relevant discipline is required.

Experience:

• 1-6 years relevant experience in the pharmaceutical, medical device, food or other FDA-regulated industry is required.
• Six Sigma (Green Belt/Black Belt) or LEAN master Certification a plus

Knowledge/Skills Requirements:

• Strong mechanical aptitude, problem-solving and analytical skills
• Experience with cGMP (current Good Manufacturing Practices)
• Full complement of business computer literacy skills (e.g., Microsoft Office Tools including Excel, Word, PowerPoint, Access), Visio.
• Ability to work independently on multiple projects
• Completion of OSHA 10 hour training and active knowledge/application of course content
• Demonstrated ability to read, write, and speak clear English.

Physical Requirements:

• Manufacturing and office environments
• Sit, stand and work at a computer for up to 8 hours per day
• Frequent sitting, standing walking, reading of written documents and use of computer monitor screen, talking, writing, listening
• Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balance, carrying, grasping
• Occasional lifting and/or moving up to 30 pounds

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.