Automation Engineer III

Automation Engineer III

Position Summary:

• Work Schedule: Monday – Friday from 8am-5pm, overtime as needed depending on production
• 100% on-site (Chelsea, MA)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and the Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring an Automation Engineer III who is expected to lead the design and implementation of automation systems for clinical and commercial manufacturing with minimal support from senior engineering staff. The candidate takes ownership of automation engineering, design, validation, and the implementation of new control systems to achieve cost effectiveness and robust manufacturing. This individual provides on-going technical support, including the maintenance, installation, startup, commissioning, testing, and qualification of automation systems.

The Role:

• Provides engineering expertise for the design, specification, and installation of pharmaceutical manufacturing automation systems. Leads automation portion of expansion and upgrade projects
• Performs and documents hardware/software modifications to existing systems. Ensures that all automation designs and technical documentation adhere to Good Manufacturing Practices (GMP) standards
• Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control equipment
• Trains users on control system functionality (Programmable Logic Controller, Computer/Control Networks, Control Computers and Instrumentation)
• Troubleshoots and diagnoses control system problems, working closely with maintenance, control technicians, and metrology
• Supports software lifecycle, and electronic records/electronic signature compliance efforts
• Supports change controls and technical aspects of control equipment investigations, as applicable
• All other duties as assigned

The Candidate:

• Bachelor’s Degree in Chemical, Electrical or Mechanical Engineering required
• Must have at least three (3) years of relevant experience (defined below)
• Experience with Rockwell/Allen-Bradley batch control systems or equivalent is required. Experience with other control systems (Siemens, Schneider, etc.) is preferred
• Requires knowledge of: pharmaceutical process equipment and Clean In Place (CIP) systems, ANSI/ISA-88 Batch Control Standard, Allen Bradley/Rockwell FactoryTalk Process Control System, and relational databases and process automation protocols
• Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds

Pay:

• The anticipated salary range for this role in Massachusetts is $100,000 to $130,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.  Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!