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Job Title: Assembly Project Engineer
Department/Group: Engineering
Location: Linden Road
1st shift
Summary of Objective:
Design packages, processes, and tooling for assembly and packaging pharmaceutical products in a consistent, high-quality package that complies with cGMP's and customer requirements.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following, but other duties may be assigned.
- Quote tooling and processes for existing or new equipment weekly.
- Track tooling and equipment project costs versus planned expenditure.
- Design assembly and package line layouts for pharmaceutical products weekly. Design/purchase tooling for Assembly and packaging equipment weekly.
- Act as technical Subject Matter Expert (SME) to support customer project team meetings weekly.
- Write/revise and execute vendor Factory Acceptance tests as required. 3 per year.
- Attend Sales meetings weekly.
- Develop critical process parameters for assembly and packaging equipment. Interface with material suppliers on process assembly requirements to provide safe and effective assembled and packaged products.
- Design and implement parts and processes for line improvements monthly. Provide information on product contact materials and validation support weekly.
- Attend and support customer conference calls weekly.
- Review and approve batch records for engineering details weekly.
- Attendance to work is an essential function of this position.
- Other duties as assigned by the supervisor/manager.
- Adherence to all PCI and cGMP policies, procedures, rules, and regulations.
- This job has no supervisory responsibilities.
- This position may require overtime and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
- Performs other duties as assigned by the Manager/Supervisor.
Qualifications: The requirements listed below are representative of the knowledge, skills, and/or abilities required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Required:
- Bachelor's Degree in a related field. Must have a minimum of at least three years of experience in an FDA-regulated industry with a strong preference for medical devices or combination products.
- Minimum 3-5 years of related experience and/or training in project and process engineering roles
- College-Level Mathematical Skills
- Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
Preferred:
- Ability to demonstrate attention to detail.
- Drug Delivery medical device
- Ability to travel.
- Ability to work independently and/or as part of a team.
- Ability to follow instructions and respond to management direction.
- Design in SolidWorks is a major requirement. AutoCAD design work is a plus.
- Previous medical device assembly experience
- Design of thermoformed or cold-formed blister tooling, pouching tooling, cartoning tooling, and/or bottling tooling is a plus.
The hiring rate for this position is $$77,600 -$87,300 annually, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Top Skills
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
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