Project Specialist - Commissioning and Qualification

Tekhawks LLC.; Indiana; On-site; USD 90,000 - 130,000; Full time

Job summary

Tekhawks LLC. seeks a Project Engineer with extensive Commissioning & Qualification (C&Q) experience to contribute to a major peptide manufacturing facility project.

You will work directly with the Peptide 1 Building Node Lead to manage engineering and project execution activities, coordinate technical actions, and support key project decisions. The role involves managing engineering packages, facilitating technical meetings, reviewing drawings for redlines, and ensuring deliverables meet

Qualifications

• Strong practical knowledge of commissioning and qualification processes.
• Background supporting major pharmaceutical manufacturing projects within GMP-regulated facilities.
• Experience in API manufacturing environments strongly preferred.
• Direct exposure to peptide API production facilities highly desirable.
• Ability to evaluate engineering designs and drawings and provide accurate technical redlines.

Responsibilities

• Work with the Peptide 1 Building Node Lead to manage ongoing engineering and project execution activities.
• Provide engineering coordination and execution support to the broader project leadership team.
• Own assigned project packages, technical activities, and deliverables through final completion.
• Facilitate project meetings, coordinate team discussions, and ensure timely closure of actions.
• Review engineering drawings and design packages; provide redlines and identify necessary modifications.
• Coordinate activities across Engineering, C&Q, Construction, Operations, Quality, and vendors.
• Assist commissioning, qualification, and validation activities during project implementation.
• Monitor project schedules, deliverable status, risks, and milestones.
• Oversee contractor and supplier coordination for designated scopes.
• Support design assessments, field inspections, and site walkdowns.

Job description

Location: Indiana

Duration: 12+ months

Job Description:

We are seeking a Project Engineer with extensive Commissioning & Qualification (C&Q) experience to contribute to a major peptide manufacturing facility project. The engineer will work directly with the Node Lead overseeing the Peptide 1 Building, helping manage project execution, coordinate technical activities, and support key project decisions.

The successful candidate will be responsible for managing designated engineering packages and smaller project initiatives, facilitating technical meetings, aligning cross-functional teams, reviewing and marking up engineering drawings, and ensuring deliverables meet project timelines. Experience with large pharmaceutical capital projects is essential, while expertise in API production and peptide manufacturing will be a significant advantage.

• Work alongside the Peptide 1 Building Node Lead to manage ongoing engineering and project execution activities.
• Provide engineering coordination and execution support to the broader project leadership team.
• Take responsibility for assigned project packages, technical activities, and deliverables through final completion.
• Facilitate project meetings, coordinate team discussions, and ensure timely closure of action items.
• Examine engineering drawings and design packages, provide redlines, and identify necessary technical modifications.
• Coordinate project activities across Engineering, C&Q, Construction, Operations, Quality, and vendor organizations.
• Contribute to commissioning, qualification, and validation-related activities throughout project implementation.
• Maintain visibility into project schedules, deliverable status, technical risks, and milestone commitments.
• Oversee contractor and supplier coordination for designated engineering and construction scopes.
• Support design assessments, field inspections, site walkdowns, and construction-related technical discussions.
• Coordinate engineering requirements for process equipment, facility systems, utilities, and manufacturing infrastructure.
• Assist in preparing systems for handover, commissioning completion, startup, and operational use.
• Troubleshoot technical challenges and coordinate corrective actions to maintain project progress.

Qualifications:

• Strong practical knowledge of commissioning and qualification processes.
• Background supporting major pharmaceutical manufacturing projects within GMP-regulated facilities.
• Previous experience in API manufacturing environments is strongly preferred.
• Direct exposure to peptide API production facilities is highly desirable.
• Ability to evaluate engineering designs and drawings and provide accurate technical redlines.
• Demonstrated experience working with contractors, equipment vendors, and cross-functional engineering teams.
• Proven ability to manage individual workstreams independently and achieve defined project objectives.
• Excellent communication, meeting facilitation, coordination, and organizational capabilities.
• Ability to work effectively in an active construction and field-based setting.
• Physical ability to access different areas of the facility, including climbing scaffolding when necessary.