Anika · 4 months ago
Process Automation Engineer
Bedford, MA
Full-time
Onsite
Mid, Senior Level
5+ years expAnika Therapeutics is focused on pharmaceutical manufacturing excellence, and they are seeking a Process Automation Engineer to design, implement, and support automated control systems. This role involves collaboration with cross-functional teams to ensure compliance with regulatory standards and optimize automation systems for performance and reliability.
BiotechnologyHealth CareManufacturingTherapeutics
Responsibilities
Lead the design and specification of process automation systems in alignment with cGMP, GAMP, and other relevant standards
Develop and maintain: User Requirement Specifications (URS), Functional Design Specifications (FDS), Software Design Specifications (SDS), Hardware Design Specifications (HDS), Configuration Specifications (CS), etc
Troubleshoot and resolve issues related to automation hardware and software in manufacturing environments
Update control system software to accommodate process changes, device integration, and performance enhancements
Collaborate with validation teams to ensure automation systems meet commissioning and qualification protocols
Support FAT/SAT activities and documentation for automated equipment and systems
Ensure automation systems comply with internal procedures, data integrity principles, and regulatory standards
Partner with Manufacturing, Engineering, Maintenance, Quality, and IT to ensure systems are user-centric, compliant, and aligned with operational goals
Serve as the primary liaison between Operations and IT, ensuring computerized systems are properly maintained and optimized
Manage relationships with equipment vendors to ensure timely delivery, technical alignment, and quality performance
Coordinate with systems integrators to execute complex automation projects, ensuring seamless integration and scalability
Lead software upgrade projects across control platforms, ensuring minimal disruption and full compliance with validation requirements
Develop and deploy software bug fixes, enhancements, and performance improvements across automation platforms
Maintain and enhance automation support tools such as data historians and software revision control systems
Identify and implement high-value, achievable improvements to automation systems and manufacturing processes
Evaluate and integrate new data management tools and technologies to improve system performance and data accessibility
Contribute to capital project execution, including design reviews, installation oversight, and system integration
Promote safety awareness and ensure proper use of protective equipment in all engineering activities
Provide technical support to metrology and calibration teams to deploy assets with effective process ranges and calibration job plans
Support manufacturing, engineering and facilities with equipment troubleshooting, at times off-hours, to reduce maintenance time and increase process reliability
Qualification
Required
Bachelor's degree in Automation Engineering, Computer Science Engineering, Mechanical Engineering, Electrical Engineering, or equivalent experience
Minimum of 5 years in automation engineering within a manufacturing environment, preferably in the med device and/or biopharmaceutical industry
Proficiency with automation platforms such as Rockwell Automation, Ignition, Siemens, Wonderware and Modicon
Experience with Johnson Controls (JCI) Building Management Systems is a plus
Proven ability to lead software upgrade projects, implement bug fixes, and optimize system performance
Track record of successfully leading and supporting capital and automation projects from concept through execution
Strong verbal and written communication skills, with the ability to collaborate effectively across departments and with external partners
Familiarity with cGMP, GAMP, and data integrity principles, with a strong understanding of compliance in regulated environments
Experience managing vendor relationships and partnering with systems integrators on complex automation initiatives
Solid understanding of networking, computerized systems, and data management tools used in manufacturing environments
Company
Anika
Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.
201-500 employees
H1B Sponsorship
Anika has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
Caligan Partners
2024-03-07Post Ipo Equity
1993-05-14IPO
Leadership Team
Cheryl Blanchard
President and CEO
Recent News
GlobeNewswire
2026-01-09
2026-01-09
2025-12-31
Company data provided by crunchbase