Senior Automation Engineer

COMPANY OVERVIEW

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

Our family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is now part of Noramco. We are stronger together!

100% onsite position at 30 N. Jefferson Rd, Whippany, NJ

POSITION SUMMARY

The Sr. Automation Engineer focuses on designing, implementing, integrating, maintaining and optimizing automation technologies that control, monitor and support the GMP manufacturing process and associated utilities, ensuring sterile conditions and compliance with Bio-Pharmaceutical’s industry standards.

• Lead a cross-functional team in the rollout of a new SCADA system, to enhance operational efficiency and gain a faster response time to critical issues
• Spearhead migration of legacy control systems to modern platforms
• Create automation systems for aseptic processing, Clean-In-Place (CIP), and Sterilize-In-Place (SIP) processes
• Develop PLC and HMI programming to integrate new technology that enhanced the precision of automated equipment.
• Author and execute validation documentation (URS, FS, DS, IQ, OQ, PQ).
• Manage and document all automation-related activities and projects
• Install, test, and validate automated systems to ensure they meet stringent industry standards of regulatory requirements and improve system reliability
• Develop and maintain audit trail reviews, system access control, and backup/restore procedures.
• Troubleshoot and optimize pick-and-place logic, vision systems, and robot-HMI interfaces.
• Support installation, configuration, and programming of robotics used in aseptic filling, loading/unloading, and packaging operations.
• Identify and resolve issues in automated systems to maintain peak performance. Exhibit strong ability to perform Risk Analysis to determine the nature and severity of potential risk of software being validated so as appropriate actions taken to mitigate the risks
• Collaborates with IT, Validation and QA teams to standardize and optimize automation engineering practices for process and facilities equipment.
• Conduct regular maintenance and inspections of automation equipment
• Apply FDA General Principles of Software Validation (eg. 21 CFR Part 11 Compliance) and ensure all automation activities comply with industry regulations across software validation projects
• Provide support to Sterile, Manufacturing and Packaging teams related to automation issues.
• Manage the design and implementation of automated systems and perform the qualification or validation steps (FAT, SAT, commissioning, IQ, OQ and PQ) according to GAMP 5.
• Establish and maintain technical standards and SOPs for automated systems and equipment (Building, Sterile, Manufacturing and packaging equipment), and associated network infrastructure.
• Implement updates of the systems, coordinate/perform the preventive and corrective maintenance on automated systems; update the technical and validation documentation after modifications on systems.

POSITION QUALIFICATIONS

EDUCATION:

• Bachelor's degree in electrical, mechanical, or automation engineering, or a related field

EXPERIENCE:

· 5 years of experience in automation engineering, preferably in the pharmaceutical or medical device industry.

· Understanding of industry-specific regulatory requirements

· Strong analytical and troubleshooting skills

· Ability to work independently and in a team environment

· Understanding of lean processes.

· Proficient in reading blueprints, schematics, and specification sheets.

· Ability to stand, walk, and move around the facility for extended periods.

· Frequent bending, kneeling, and reaching to inspect or troubleshoot equipment.

· Ability to lift and carry up to 25-50 lbs occasionally (e.g., tools, parts, or equipment).

· Ability to climb stairs and ladders to access elevated platforms or automation systems.

· Wearing personal protective equipment (PPE) such as safety glasses, gloves, steel-toed boots, and hearing protection as required.

· Knowledge of SCADA systems

· Proficiency in PLC programming (e.g., Siemens, Allen Bradley) and HMI/SCADA systems

Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background

Halo 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.