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ADPS Group is seeking a Senior Process Engineer for a client in Boston, MA. The Senior Process Engineer is responsible for providing GXP Engineering support functions for various GxP Operations. The role will provide technical support, including drawing review, design review, specification review, project management, change control and commissioning for GMP manufacturing equipment and facilities in a manner compliant with regulatory expectations, company policy, and current procedures.
Role Accountabilities
- Execute change management for manufacturing equipment and other support systems including commissioning and / or implementation of other related initiatives as assigned.
- Execute assigned duties on time and within budget; pro-actively communicate delays and other issues to relevant stakeholders.
- Manage creation and revision of protocols, reports, and engineering documents including, but not limited to, IOV, drawings, user requirement specifications and SOP’s.
- Effectively work with cross departmental stakeholders to achieve departmental goals and objectives.
- Supply GEP (Good Engineering Practice) expertise drawn from own experience and / or supplemented by external resources to trouble shoot facility, equipment or system issues.
- Balance the degree of innovative exploration with pursuit of project objectives and coordinate implementation / integration of new capabilities as appropriate.
Skills And Qualifications
B.A., B.S. in Engineering or related discipline with at least 5 years of relevant experience or M.S. in related field with 3 years of experience.Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.Knowledge of facility-related engineering disciplines (MEP) in GMP manufacturing environment, preferably oral solid dosage or related experience.Extensive hands‑on experience dealing with change controls.Excellent verbal and written communication skills applied on a global or multi‑national basis.Strong interpersonal skills, including the demonstrated ability to manage through influence.IDEAL CANDIDATES
Demonstrate planning and organizational skills, including complex project management.Ability to lead by influence.Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non‑Conformances, Requalification, etc).Foster change and innovation – seeks solutions that strengthen quality, value, service and effectiveness.Demonstrate business acumen and business agility – demonstrates functional / technical proficiency, engages in effective operational and strategic planning.Accountable for Results – translates goals / objectives into actionable plans and results.Able to work on multiple projects and manage various priorities and timelines.Ability to review Engineering Document and Models (CAD, Revit etc.).Ability to use Project Management tools.Additional
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Continuous Learning – assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.Culture – supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best‑in‑practice development, and pride in workmanship.Customer Services – displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.Planning and Organizing – prioritizes and plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, sets goals and objectives. Works in an organized manner.Teamwork – balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.Use of Technology – demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.Language Ability – read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.Mathematical Ability – work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.Reasoning Ability – apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.The Company
ADPS Group is a global EPCMV firm offering full‑service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. ADPS is dedicated to delivering successful projects with a ‘client‑first’ mentality and personal touch across a range of market sectors : Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start‑up.
ADPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of : race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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