Pharmaceutical C&Q Engineer

Job Title: Pharmaceutical C&Q Engineer Location: Lebanon, IN

Experience: 7+ years Duration: 12+ Months

Overview: We are seeking a detail-oriented Pharmaceutical C&Q Engineer to support the commissioning and qualification of equipment and systems in an API manufacturing facility. This role is ideal for candidates with hands-on experience in API, peptide synthesis, and purification processes, combined with C+Q and GMP expertise. Candidates with solely validation experience will not be considered.

Key Responsibilities:

Report to the C&Q Node Lead with updates on project progress, risks, and issues.

Maintain and update C&Q trackers, schedules, and dashboards to support project visibility and decision-making.

Review and interpret engineering drawings, specifications, and technical documents.

Track procurement, equipment arrivals, installations, and system milestones in coordination with construction, engineering, operations, and C&Q service teams.

Participate in C&Q execution readiness and field activities, including system and equipment walkdowns to ensure compliance with design specifications, HSE, and operational standards.

Coordinate with cross-functional teams to resolve issues and maintain project alignment.

Attend meetings, take minutes, and follow up on action items.

Ensure all documentation is maintained according to GMP and internal quality standards.

Qualifications

• Bachelor’s degree in Chemical Engineering preferred; Mechanical Engineering considered.

• 7+ years of experience in commissioning and qualification (C&Q) activities within pharmaceutical or biotechnology environments.

• Strong background in API manufacturing, peptide synthesis, and purification processes.

• Familiarity with piping design and instrumentation (direction provided by Node Leads).

• Soft Skills:

• Adaptable and able to work in fast-paced environments

• Team-oriented with strong communication and interpersonal skills

• Must-Have:

• Synthesis and purification experience

• API experience

• Peptides knowledge

• C&Q expertise

• GMP background