Cnc Manufacturing Engineer
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can choose which to include. If we include both Pay and Benefits, that's two sections. Could be okay if both have content. But we could combine into one Benefits section that includes pay info? Might be considered thin? However they said prefer few substantive sections over many thin ones. Having both Pay and Benefits might be okay if each has substantive content. Pay: just a range. Benefits: list. Could be okay. Schedule: not mentioned. So omit Schedule. Requirements/Qualifications: we have Essential Skills (which includes qualifications like BS, 2 years experience). Could treat as Requirements/Qualifications. Also Additional Skills & Qualifications. Could combine into Requirements. We need to avoid filler like "commensurate with experience". Not present. We must remove boilerplate: About Actalent, equal opportunity, accommodation, etc. Also remove Application Deadline? Might be considered metadata but not boilerplate; but it's not a section heading; we could fold into short p if we want to keep? The instruction: "Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it." Application Deadline is minor metadata; we could drop it or fold into a short p. Probably drop it. Work Environment: could be part of About the role. Thus sections: About the role (h3), Responsibilities (h3), Requirements (h3) (or Qualifications), Skills (h3) maybe combine Essential Skills and Additional Skills into Skills. Benefits (h3), Pay (h3). Could also have Work Environment as part of About. We need to preserve all substantive information; not invent or summarize away detail. So we must keep all bullet points from Responsibilities, Essential Skills, Additional Skills & Qualifications, Benefits list, Pay range. We must not duplicate lines. Let's extract: About the role paragraph: "This Manufacturing Engineer role focuses on developing, executing, and managing installation, qualification, and validation documentation and protocols for process equipment in a regulated manufacturing environment. The position supports a wide range of equipment qualifications, including CNC machines, and plays a key role in ensuring compliance with cGMP regulations and quality management system requirements. The engineer will collaborate closely with cross-functional teams, lead validation activities, and provide technical guidance to enhance equipment and process validation capabilities." That's the description. Responsibilities bullet list (each line starts with a verb). Let's list them: - Develop, execute, and manage installation, qualification, and validation documents and protocols for process equipment. - Support a wide variety of equipment qualifications, including CNC machines and related manufacturing equipment. - Guide, mentor, and cross-train team members to expand equipment and process validation capabilities. - Create and manage change requests in Windchill to support equipment moves and related configuration changes. - Execute project plans and schedules to ensure timely completion of validation and engineering activities. - Handle non-conformances, including investigation, documentation, and resolution activities. - Conduct Issue Evaluations and support the implementation and closure of Corrective and Preventive Actions (CAPAs). - Collaborate effectively with cross-functional teams to complete critical project tasks and validation deliverables. - Communicate clearly in both written and verbal form with personnel from other departments to coordinate work and resolve issues. - Provide recommendations on process improvements, procedures, and training based on validation findings and quality data. - Prepare and maintain technical documentation, including validation protocols, reports, and supporting records. - Apply quality and statistical tools to analyze data, troubleshoot issues, and support continuous improvement initiatives. Essential Skills bullet list: - Strong knowledge of current Good Manufacturing Practice (cGMP) regulations, including FDA and EMA requirements. - Experience writing and executing validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation. - Proficiency in validation of manufacturing equipment, utilities, cleaning processes, and computer systems. - Good problem-solving skills using quality and statistical tools to identify root causes and implement effective solutions. - Ability to work effectively within cross-functional teams to complete critical project tasks and validation activities. - Strong written and verbal communication skills for interacting with technical and non-technical stakeholders. - Strong technical writing and documentation skills for authoring protocols, reports, and supporting documentation. - Ability to independently develop and execute project plans and manage multiple tasks in a regulated environment. - Demonstrated ability to take initiative and provide recommendations on processes, procedures, and training needs. - Working knowledge of Quality Management Systems, including Nonconformance and Issue Evaluation processes. - Experience in manufacturing engineering with focus on equipment qualification and quality management systems. - Bachelor of Science (B.S.) in Engineering. - Minimum of 2 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry. Additional Skills & Qualifications bullet list: - Hands-on experience with CNC machines and related manufacturing equipment in a regulated environment. - Experience in manufacturing engineering supporting equipment qualification and process validation. - Familiarity with medical device manufacturing practices and regulatory expectations. - Experience using Product Lifecycle Management (PLM) tools such as Windchill to manage change requests. - Exposure to utilities and cleaning process validation in pharmaceutical or biotech operations. - Comfort working with statistical and quality tools to support validation and continuous improvement projects. - Ability to mentor and cross-train colleagues to build broader validation capabilities within the team. Work Environment paragraph (could be part of About). But we might keep as separate? Not required. Job Type & Location: "This is a Contract position based out of Warsaw, IN." Could be short p. Pay And Benefits: Pay range: "$35.00 - $40.00/hr." Benefits list: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type: "This is a fully onsite position in Warsaw,IN." Could be short p. Application Deadline: drop. About Actalent etc: remove. Now produce HTML fragment. We'll have:
About the role
...
Responsibilities
- ... ...
Requirements
Maybe combine Essential Skills and Additional Skills? But we could have Requirements (education, experience) and Skills separate. However we have many skill bullets. Could make Requirements for education/experience, Skills for technical abilities. But we risk thin sections. Let's think: Essential Skills includes both knowledge/experience and skills. Additional Skills & Qualifications also similar. Could combine all into Skills section. Then we might not need Requirements. But we have education and years experience which are qualifications. Could put them in Requirements. Thus:
Requirements
- Bachelor of Science (B.S.) in Engineering.
- Minimum of 2 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.
Skills
-
Combine Essential Skills (excluding the two we moved) plus Additional Skills & Qualifications.
Essential Skills list items (excluding the two we moved):
- Strong knowledge of current Good Manufacturing Practice (cGMP) regulations, including FDA and EMA requirements.
- Experience writing and executing validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
- Proficiency in validation of manufacturing equipment, utilities, cleaning processes, and computer systems.
- Good problem-solving skills using quality and statistical tools to identify root causes and implement effective solutions.
- Ability to work effectively within cross-functional teams to complete critical project tasks and validation activities.
- Strong written and verbal communication skills for interacting with technical and non-technical stakeholders.
- Strong technical writing and documentation skills for authoring protocols, reports, and supporting documentation.
- Ability to independently develop and execute project plans and manage multiple tasks in a regulated environment.
- Demonstrated ability to take initiative and provide recommendations on processes, procedures, and training needs.
- Working knowledge of Quality Management Systems, including Nonconformance and Issue Evaluation processes.
- Experience in manufacturing engineering with focus on equipment qualification and quality management systems.
Additional Skills & Qualifications:
- Hands-on experience with CNC machines and related manufacturing equipment in a regulated environment.
- Experience in manufacturing engineering supporting equipment qualification and process validation.
- Familiarity with medical device manufacturing practices and regulatory expectations.
- Experience using Product Lifecycle Management (PLM) tools such as Windchill to manage change requests.
- Exposure to utilities and cleaning process validation in pharmaceutical or biotech operations.
- Comfort working with statistical and quality tools to support validation and continuous improvement projects.
- Ability to mentor and cross-train colleagues to build broader validation capabilities within the team.
We should ensure no duplication: Some items overlap (e.g., experience in manufacturing engineering supporting equipment qualification appears both in Essential Skills and Additional). We need to avoid duplicate lines. Let's deduplicate.
Essential Skills includes "Experience in manufacturing engineering with focus on equipment qualification and quality management systems." Additional includes "Experience in manufacturing engineering supporting equipment qualification and process validation." Slightly different but similar. Keep both? Might be considered duplicate-ish but not exact. We'll keep both as they are distinct phrasing.
Also "Ability to mentor and cross-train colleagues..." appears in Additional; also "Guide, mentor, and cross-train team members..." is in Responsibilities, not skills. So fine.
Now Benefits and Pay sections.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Benefits
Pay
The pay range for this position is $35.00 - $40.00/hr.
We may also include Job Type & Location and Workplace Type as short p after Pay? Could fold into a short p under a generic "Job Details" but not required. The instruction: "Do NOT put