Facility and Engineering Lead - Albion Rye Associates

Job Summary:

This client, who is a leader in the drug delivery system space, is seeking a professional to oversee and supervise the Facilities, Maintenance, and Metrology departments, ensuring compliance with cGMP standards for pharmaceutical manufacturing under CFR 211 guidelines.

Key Responsibilities:

• Ensure that all Maintenance and Metrology team members carry out their duties in accordance with procedures, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Safety Policies.
• Coordinate and supervise the Maintenance and Metrology teams to ensure that all core tasks are completed in line with company procedures, cGMP, DEA, and CFR 211 requirements. Core tasks include: Preventive Maintenance (PMs), Work Orders (WOs), and calibrations.
• Review and approve PMs, WOs, and calibration records.
• Organise, prioritise, and track any outstanding issues and opportunities for improvement.
• Oversee and guide the completion of support and improvement work, ensuring adherence to company procedures, cGMP, DEA, and CFR 211. This includes deviation investigations, Preventive Actions (PAs), Change Controls, and biennial MSOP/PMSOP reviews.
• Review and approve deviations and PAs not executed personally.
• Initiate and manage Change Controls related to facilities or projects.
• Conduct Pareto analysis on maintenance and facility issues, proposing solutions for team and manager discussions.
• Coach and develop Maintenance and Metrology associates, building the team as required.
• Provide periodic metrics and updates to the Director of Operations for inclusion in periodic reports.
• Represent the Maintenance department in Change Control, Biennial Review, and other relevant meetings. Assign and track tasks as needed.
• Ensure effective communication within and between shifts, departments, and all levels of the organisation.
• Maintain workflow and ensure the availability and proper use of materials and tools.
• Ensure that facilities are maintained and cleaned in line with company procedures and GMP expectations.
• Analyse and resolve work-related problems, providing guidance to associates where necessary.
• Develop and revise Standard Operating Procedures (SOPs) and Standard Forms in accordance with company processes.
• Collaborate in the development of new products, processes, and equipment.
• Lead the implementation and ongoing maintenance of LEAN 6S activities within the maintenance department.
• Carry out performance assessments and provide continuous coaching for operators.
• Manage disciplinary actions and assist in creating proficiency plans for improvement.
• Where necessary, perform direct work, demonstrating the ability to carry out all operations within the department in accordance with documented procedures (QSOP, MSOP, MBR, etc.), protocols, deviations, and training lessons.
• Ensure compliance with all relevant regulations (e.g., ISO, FDA, HSE, EPA, DEP) and company procedures.

Job Specifications:

• A college degree is preferred.
• A minimum of 2 years’ management experience in a manufacturing environment is essential.
• Professional conduct and respect towards all associates is expected.
• Experience in a cGMP manufacturing environment is preferred.
• A solid understanding of manufacturing operations, systems, and related processes is required.
• The ability to work independently with minimal supervision is essential.
• Strong written and verbal communication skills are a must.
• Ability to write SOPs (Standard Operating Procedures).
• Ability to comprehend and follow written procedures, including operating procedures, protocols, and training lessons.
• Experience in troubleshooting equipment and processes, identifying corrective actions.
• Proven ability to lead others in task execution.
• Ability to recognise when PPE is required and wear the appropriate protective equipment, such as safety glasses, sleeve covers, and gloves. At times, additional PPE, such as masks, may be necessary for extended periods.
• Basic mathematical and statistical skills, including the ability to calculate means and perform basic rounding.
• Precision and accuracy when working with numbers, including the ability to read, calculate, and document figures consistently.
• Flexibility in schedule and routine to accommodate changes in inventory and production schedules.
• The work environment may involve moderate risks or discomforts that require special safety precautions, including working with moving parts, machines, and potentially irritant chemicals. Personal protective equipment such as gowns, gloves, safety glasses, and other PPE will be required.
• Physical exertion may be required, such as standing for long periods, bending, crouching, and stretching.
• Proficiency with MS Word, MS Excel, and MS SharePoint is necessary.
• Experience with Lean Principles is preferred.

Compensation:

This permanent position offers an annual salary between $125,000-$140,000, alongside medical insurance, 401k, and other benefits. The final package will depend on factors such as location, education, qualifications, experience, and individual performance.

If you are a proactive, experienced leader with a strong background in maintenance and metrology within a regulated manufacturing environment, this is a great opportunity for you.

How to Apply:

To apply, please submit your CV and a cover letter directly through this job ad, or contact me on: murray.jardine@albionryeassociates.com