Tech Services - Senior Associate Engineer

Role Summary

Senior Tech Ops Engineer responsible for strategic direction and technical execution of site Commissioning and Qualification (C&Q) activities for equipment, utilities and facilities. Drives alignment with global standards, supports capital projects, and shapes the site technology roadmap to enable operational excellence.

Responsibilities

• Act as the SME for C&Q work for Utilities, Facilities and Equipment; apply knowledge of design reviews, commissioning and qualification for pharmaceutical systems.
• Collaborate with cross-functional groups for process improvements; apply pharma regulations and cGMP principles; interface with auditors and present on-site processes.
• Organize, coordinate and support testing for new process technologies and system introductions; ensure C&Q of site systems aligns with procedures and industry guidance.
• Plan, generate, review and approve site technical reports, including validation plans/protocols, design specs, and risk assessments.
• Ensure site alignment to global C&Q procedures and provide training, guidance and templates to Focus Factory technical teams.
• Confirm C&Q pre-requisites are met with approved documentation; oversee and assist team members and contractor resources; support development of C&Q strategies and validation documentation.
• Contribute to technology transfer, risk assessments, deviation investigations, CAPA actions; participate in change control teams for new and existing systems.

Qualifications

• Required: Bachelor‚Äôs degree with 2+ years of experience; or Master‚Äôs with 0+ years; or Associate‚Äôs with 6 years; or high school diploma with 8 years of relevant experience.
• Solid knowledge of C&Q strategies; understanding of pharmaceutical equipment, utilities, and facility systems (pref. sterile injectable operations).
• Strong leadership, organizational, and project management skills; ability to work with multi-disciplinary teams.
• Self-motivated with minimal direction; strong interpersonal and communication skills (written and oral); ability to interact with multiple levels of the organization.
• Aptitude for understanding process technology and controls applications; ability to make decisions and manage priorities in a dynamic environment; understanding of GMP regulations.

Skills

• Technical writing experience (preferred).
• Experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems (sterile products/medical devices) (preferred).
• Knowledge of FDA regulations/guidance and GMP (preferred).
• Ability to work independently and with others; initiative and results-driven mindset.

Education

• Educational background as listed in qualifications (Bachelor‚Äôs/Master‚Äôs/Associate‚Äôs/High School with relevant experience).

Additional Requirements

• Physical/mental: able to travel, stand for extended periods, climb ladders, lift up to 25 lbs; adaptable to fast-paced environment; prepare for rotating shifts as needed.
• Travel: ability to travel as required; occasional on-site or factory acceptance testing support.